Can exercise “therapy” and diet improve survival in patients with colon cancer? It appears so, according to two pivotal studies presented at American Society of Clinical Oncology (ASCO) 2025 annual meeting.

In the CHALLENGE trial, a structured exercise program after surgery and adjuvant chemotherapy cut the risk for colon cancer recurrence in patients with stage III and high-risk stage II disease by more than one quarter and the risk for death by more than one third.

“The magnitude of benefit with exercise is substantial. In fact, it is comparable, and in some cases exceeds the magnitude of benefit of many of our very good standard medical therapies in oncology,” study presenter Christopher Booth, MD, with Queen’s University, Kingston, Ontario, Canada, told attendees.

Results of the study were published online in The New England Journal of Medicine to coincide with the presentation at the meeting.

The findings are “nothing short of a major milestone,” said study discussant Peter Campbell, PhD, with Montefiore Einstein Comprehensive Cancer Center, Bronx, New York.

The other study showed that eating a less inflammatory diet may reduce the risk for death in patients with colon cancer, with the greatest benefits seen in those who embraced anti-inflammatory foods and exercised regularly.

“Putting these two abstracts into perspective, we as physicians need to be essentially prescribing healthy diet and exercise. The combination of the two are synergistic,” Julie Gralow, MD, ASCO chief medical officer and executive vice president, told attendees.

Despite the benefits of these lifestyle changes, exercise and diet are meant to supplement, not replace, established colon cancer treatments.

It would be a false binary to frame this as lifestyle vs cancer treatment, explained Mark Lewis, MD, director of Gastrointestinal Oncology at Intermountain Healthcare in Salt Lake City, Utah. With exercise, for instance, “the key is giving enough chemo to protect against recurrence and eliminate micrometastases but not so much that we cause neuropathy and reduce function and ability to follow the CHALLENGE structured program,” Lewis said.

Exercise and Survival

Colon cancer remains the second-leading cause of cancer death worldwide. Even with surgery and chemotherapy, roughly 30% of patients with stage III and high-risk stage II colon cancer will experience disease recurrence.

“As oncologists, one of the most common questions we get asked by patients is — what else can I do to improve my outcome?” Booth said.

Observational studies published nearly two decades ago hinted that physically active cancer survivors fare better, but no randomized trial has definitively tested whether exercise could alter disease course. That knowledge gap prompted the Canadian Cancer Trials Group to launch the CHALLENGE trial.

Between 2009 and 2023, the phase 3 study enrolled 889 adults (median age, 61 years; 51% women) who had completed surgery and adjuvant chemotherapy for stage III (90%) or high-risk stage II (10%) colon cancer. Most patients were from Canada and Australia and were enrolled 2-6 months after completing chemotherapy.

Half of study participants were randomly allocated to a structured exercise program (n = 445) and half to receive standard health education materials promoting physical activity and healthy eating (control individuals, n = 444).

As part of the structured exercise intervention, patients met with a physical activity consultant twice a month for the first 6 months. These sessions included exercise coaching and supervised exercise. Patients could choose their preferred aerobic exercise and most picked brisk walking.

The consultants gave each patient an “exercise prescription” to hit a specific amount of exercise. The target was an additional 10 metabolic equivalent (MET)–hours of aerobic activity per week — about three to four brisk walks each lasting 45-60 minutes. After 6 months, patients met with their consultants once a month, with additional sessions available for extra support if needed.

Structured exercise led to “substantial and sustained” increases in the amount of exercise participants did, as well as physiologic measures of their fitness, with “highly relevant” improvements in VO₂ max, 6-minute walk test, and patient-reported physical function, underscoring that participants were not only exercising more but also getting fitter, Booth said.

Exercise was associated with a clinically meaningful and statistically significant 28% reduction in the risk for recurrent or new cancer (hazard ratio [HR], 0.72; P = .017), with a 5-year disease free survival rate of 80% in the exercise group and 74% in the control group.

In other words, “for every 16 patients that went on the exercise program, exercise prevented 1 person from recurrent or new cancer” at 5 years, Booth reported.

Overall survival results were “even more impressive,” he said.

At 8 years, 90% of patients in the exercise program were alive vs 83% of those in the control group, which translated to a 37% lower risk for death (HR, 0.63; P = .022).

“For every 14 patients who went on the exercise program, exercise prevented 1 person from dying” at the 8-year mark, Booth noted.

“Notably, this difference in survival was not driven by difference in cardiovascular deaths but by a reduction in the risk of death from colon cancer,” he said.

Besides a slight uptick in musculoskeletal aches, no major safety signals emerged in the exercise group.

It’s important to note that the survival benefit associated with exercise came after patients had received surgery followed by chemotherapy — in other words, exercise did not replace established cancer treatments. It’s also unclear whether initiating an exercise intervention earlier in the treatment trajectory — before surgery or during chemotherapy, instead of after chemotherapy — could further improve cancer outcomes, the authors noted.

Still, “exercise as an intervention is a no brainer and should be implemented broadly,” said ASCO expert Pamela Kunz, MD, with Yale School of Medicine, New Haven, Connecticut.

Marco Gerlinger, MD, with Barts Cancer Institute, London, England, agreed.

“Oncologists can now make a very clear evidence-based recommendation for patients who just completed their chemotherapy for bowel cancer and are fit enough for such an exercise program,” Gerlinger said in a statement from the nonprofit UK Science Media Centre.

Booth noted that knowledge alone will not be sufficient to allow most patients to change their lifestyle and realize the health benefits.

“The policy implementation piece of this is really key, and we need health systems, hospitals, and payers to invest in these behavior support programs so that patients have access to a physical activity consultant and can realize the health benefits,” he said.

“This intervention is empowering and achievable for patients and with much, much lower cost than many of our therapies. It is also sustainable for health systems,” he concluded.

Diet and Survival

Diet can also affect outcomes in patients with colon cancer.

In the same session describing the CHALLENGE results, Sara Char, MD, with Dana-Farber Cancer Institute in Boston, reported findings showing that consuming a diet high in proinflammatory foods was associated with worse overall survival in patients with stage III colon cancer. A proinflammatory diet includes red and processed meats, sugary drinks, and refined grains, while an anti-inflammatory diet focuses on fruits, vegetables, whole grains, fish, and olive oil.

Chronic systemic inflammation has been implicated in both colon cancer development and in its progression, and elevated levels of inflammatory markers in the blood have previously been associated with worse survival outcomes in patients with stage III colon cancer.

Char and colleagues analyzed dietary patterns of a subset of 1625 patients (mean age, 61 years) with resected stage III colon cancer enrolled in the phase 3 CALGB/SWOG 80702 (Alliance) clinical trial, which compared 3 months of adjuvant chemotherapy with 6 months of adjuvant chemotherapy, with or without the anti-inflammatory medication celecoxib.

As part of the trial, participants reported their diet and exercise habits at various timepoints. Their diets were scored using the validated empirical dietary inflammatory pattern (EDIP) tool, which is a weighted sum of 18 food groups — nine proinflammatory and nine anti-inflammatory. A high EDIP score marks a proinflammatory diet, and a low EDIP score indicates a less inflammatory diet.

During median follow-up of nearly 4 years, researchers noted a trend toward worse disease-free survival in patients with high proinflammatory diets (HR, 1.46), but this association was not significant in the multivariable adjusted model (HR, 1.36; P = .22), Char reported.

However, higher intake of proinflammatory foods was associated with significantly worse overall survival.

Patients who consumed the most proinflammatory foods (top 20%) had an 87% higher risk for death compared with those who consumed the least (bottom 20%; HR, 1.87). The median overall survival in the highest quintile was 7.7 years and was not reached in the lowest quintile.

Combine Exercise and Diet for Best Results

To examine the joint effect of physical activity and diet on overall survival, patients were divided into higher and lower levels of physical activity using a cut-off of 9 MET hours per week, which roughly correlates to 30 minutes of vigorous walking five days a week with a little bit of light yoga, Char explained.

In this analysis, patients with less proinflammatory diets and higher physical activity levels had the best overall survival outcomes, with a 63% lower risk for death compared with peers who consumed more pro-inflammatory diets and exercised less (HR, 0.37; P < .0001).

Daily celecoxib use and low-dose aspirin use (< 100 mg/d) did not affect the association between inflammatory diet and survival.

Char cautioned, that while the EDIP tool is useful to measure the inflammatory potential of a diet, “this is not a dietary recommendation, and we need further studies to be able to tailor our findings into dietary recommendations that can be provided to patients at the bedside.”

Gralow said this “early but promising observational study suggests a powerful synergy: Patients with stage III colon cancer who embraced anti-inflammatory foods and exercised regularly showed the best overall survival compared to those with inflammatory diets and limited exercise.”

The CHALLENGE trial was funded by the Canadian Cancer Society, the National Health and Medical Research Council, Cancer Research UK, and the University of Sydney Cancer Research Fund. Booth had no disclosures. The diet study was funded by the National Institutes of Health, Pfizer, and the Project P Fund. Char disclosed an advisory/consultant role with Goodpath. Kunz, Gralow and Campbell had no relevant disclosures.

A version of this article first appeared on Medscape.com.

Can exercise “therapy” and diet improve survival in patients with colon cancer? It appears so, according to two pivotal studies presented at American Society of Clinical Oncology (ASCO) 2025 annual meeting.

In the CHALLENGE trial, a structured exercise program after surgery and adjuvant chemotherapy cut the risk for colon cancer recurrence in patients with stage III and high-risk stage II disease by more than one quarter and the risk for death by more than one third.

“The magnitude of benefit with exercise is substantial. In fact, it is comparable, and in some cases exceeds the magnitude of benefit of many of our very good standard medical therapies in oncology,” study presenter Christopher Booth, MD, with Queen’s University, Kingston, Ontario, Canada, told attendees.

Results of the study were published online in The New England Journal of Medicine to coincide with the presentation at the meeting.

The findings are “nothing short of a major milestone,” said study discussant Peter Campbell, PhD, with Montefiore Einstein Comprehensive Cancer Center, Bronx, New York.

The other study showed that eating a less inflammatory diet may reduce the risk for death in patients with colon cancer, with the greatest benefits seen in those who embraced anti-inflammatory foods and exercised regularly.

“Putting these two abstracts into perspective, we as physicians need to be essentially prescribing healthy diet and exercise. The combination of the two are synergistic,” Julie Gralow, MD, ASCO chief medical officer and executive vice president, told attendees.

Despite the benefits of these lifestyle changes, exercise and diet are meant to supplement, not replace, established colon cancer treatments.

It would be a false binary to frame this as lifestyle vs cancer treatment, explained Mark Lewis, MD, director of Gastrointestinal Oncology at Intermountain Healthcare in Salt Lake City, Utah. With exercise, for instance, “the key is giving enough chemo to protect against recurrence and eliminate micrometastases but not so much that we cause neuropathy and reduce function and ability to follow the CHALLENGE structured program,” Lewis said.

Exercise and Survival

Colon cancer remains the second-leading cause of cancer death worldwide. Even with surgery and chemotherapy, roughly 30% of patients with stage III and high-risk stage II colon cancer will experience disease recurrence.

“As oncologists, one of the most common questions we get asked by patients is — what else can I do to improve my outcome?” Booth said.

Observational studies published nearly two decades ago hinted that physically active cancer survivors fare better, but no randomized trial has definitively tested whether exercise could alter disease course. That knowledge gap prompted the Canadian Cancer Trials Group to launch the CHALLENGE trial.

Between 2009 and 2023, the phase 3 study enrolled 889 adults (median age, 61 years; 51% women) who had completed surgery and adjuvant chemotherapy for stage III (90%) or high-risk stage II (10%) colon cancer. Most patients were from Canada and Australia and were enrolled 2-6 months after completing chemotherapy.

Half of study participants were randomly allocated to a structured exercise program (n = 445) and half to receive standard health education materials promoting physical activity and healthy eating (control individuals, n = 444).

As part of the structured exercise intervention, patients met with a physical activity consultant twice a month for the first 6 months. These sessions included exercise coaching and supervised exercise. Patients could choose their preferred aerobic exercise and most picked brisk walking.

The consultants gave each patient an “exercise prescription” to hit a specific amount of exercise. The target was an additional 10 metabolic equivalent (MET)–hours of aerobic activity per week — about three to four brisk walks each lasting 45-60 minutes. After 6 months, patients met with their consultants once a month, with additional sessions available for extra support if needed.

Structured exercise led to “substantial and sustained” increases in the amount of exercise participants did, as well as physiologic measures of their fitness, with “highly relevant” improvements in VO₂ max, 6-minute walk test, and patient-reported physical function, underscoring that participants were not only exercising more but also getting fitter, Booth said.

Exercise was associated with a clinically meaningful and statistically significant 28% reduction in the risk for recurrent or new cancer (hazard ratio [HR], 0.72; P = .017), with a 5-year disease free survival rate of 80% in the exercise group and 74% in the control group.

In other words, “for every 16 patients that went on the exercise program, exercise prevented 1 person from recurrent or new cancer” at 5 years, Booth reported.

Overall survival results were “even more impressive,” he said.

At 8 years, 90% of patients in the exercise program were alive vs 83% of those in the control group, which translated to a 37% lower risk for death (HR, 0.63; P = .022).

“For every 14 patients who went on the exercise program, exercise prevented 1 person from dying” at the 8-year mark, Booth noted.

“Notably, this difference in survival was not driven by difference in cardiovascular deaths but by a reduction in the risk of death from colon cancer,” he said.

Besides a slight uptick in musculoskeletal aches, no major safety signals emerged in the exercise group.

It’s important to note that the survival benefit associated with exercise came after patients had received surgery followed by chemotherapy — in other words, exercise did not replace established cancer treatments. It’s also unclear whether initiating an exercise intervention earlier in the treatment trajectory — before surgery or during chemotherapy, instead of after chemotherapy — could further improve cancer outcomes, the authors noted.

Still, “exercise as an intervention is a no brainer and should be implemented broadly,” said ASCO expert Pamela Kunz, MD, with Yale School of Medicine, New Haven, Connecticut.

Marco Gerlinger, MD, with Barts Cancer Institute, London, England, agreed.

“Oncologists can now make a very clear evidence-based recommendation for patients who just completed their chemotherapy for bowel cancer and are fit enough for such an exercise program,” Gerlinger said in a statement from the nonprofit UK Science Media Centre.

Booth noted that knowledge alone will not be sufficient to allow most patients to change their lifestyle and realize the health benefits.

“The policy implementation piece of this is really key, and we need health systems, hospitals, and payers to invest in these behavior support programs so that patients have access to a physical activity consultant and can realize the health benefits,” he said.

“This intervention is empowering and achievable for patients and with much, much lower cost than many of our therapies. It is also sustainable for health systems,” he concluded.

Diet and Survival

Diet can also affect outcomes in patients with colon cancer.

In the same session describing the CHALLENGE results, Sara Char, MD, with Dana-Farber Cancer Institute in Boston, reported findings showing that consuming a diet high in proinflammatory foods was associated with worse overall survival in patients with stage III colon cancer. A proinflammatory diet includes red and processed meats, sugary drinks, and refined grains, while an anti-inflammatory diet focuses on fruits, vegetables, whole grains, fish, and olive oil.

Chronic systemic inflammation has been implicated in both colon cancer development and in its progression, and elevated levels of inflammatory markers in the blood have previously been associated with worse survival outcomes in patients with stage III colon cancer.

Char and colleagues analyzed dietary patterns of a subset of 1625 patients (mean age, 61 years) with resected stage III colon cancer enrolled in the phase 3 CALGB/SWOG 80702 (Alliance) clinical trial, which compared 3 months of adjuvant chemotherapy with 6 months of adjuvant chemotherapy, with or without the anti-inflammatory medication celecoxib.

As part of the trial, participants reported their diet and exercise habits at various timepoints. Their diets were scored using the validated empirical dietary inflammatory pattern (EDIP) tool, which is a weighted sum of 18 food groups — nine proinflammatory and nine anti-inflammatory. A high EDIP score marks a proinflammatory diet, and a low EDIP score indicates a less inflammatory diet.

During median follow-up of nearly 4 years, researchers noted a trend toward worse disease-free survival in patients with high proinflammatory diets (HR, 1.46), but this association was not significant in the multivariable adjusted model (HR, 1.36; P = .22), Char reported.

However, higher intake of proinflammatory foods was associated with significantly worse overall survival.

Patients who consumed the most proinflammatory foods (top 20%) had an 87% higher risk for death compared with those who consumed the least (bottom 20%; HR, 1.87). The median overall survival in the highest quintile was 7.7 years and was not reached in the lowest quintile.

Combine Exercise and Diet for Best Results

To examine the joint effect of physical activity and diet on overall survival, patients were divided into higher and lower levels of physical activity using a cut-off of 9 MET hours per week, which roughly correlates to 30 minutes of vigorous walking five days a week with a little bit of light yoga, Char explained.

In this analysis, patients with less proinflammatory diets and higher physical activity levels had the best overall survival outcomes, with a 63% lower risk for death compared with peers who consumed more pro-inflammatory diets and exercised less (HR, 0.37; P < .0001).

Daily celecoxib use and low-dose aspirin use (< 100 mg/d) did not affect the association between inflammatory diet and survival.

Char cautioned, that while the EDIP tool is useful to measure the inflammatory potential of a diet, “this is not a dietary recommendation, and we need further studies to be able to tailor our findings into dietary recommendations that can be provided to patients at the bedside.”

Gralow said this “early but promising observational study suggests a powerful synergy: Patients with stage III colon cancer who embraced anti-inflammatory foods and exercised regularly showed the best overall survival compared to those with inflammatory diets and limited exercise.”

The CHALLENGE trial was funded by the Canadian Cancer Society, the National Health and Medical Research Council, Cancer Research UK, and the University of Sydney Cancer Research Fund. Booth had no disclosures. The diet study was funded by the National Institutes of Health, Pfizer, and the Project P Fund. Char disclosed an advisory/consultant role with Goodpath. Kunz, Gralow and Campbell had no relevant disclosures.

A version of this article first appeared on Medscape.com.

Can exercise “therapy” and diet improve survival in patients with colon cancer? It appears so, according to two pivotal studies presented at American Society of Clinical Oncology (ASCO) 2025 annual meeting.

In the CHALLENGE trial, a structured exercise program after surgery and adjuvant chemotherapy cut the risk for colon cancer recurrence in patients with stage III and high-risk stage II disease by more than one quarter and the risk for death by more than one third.

“The magnitude of benefit with exercise is substantial. In fact, it is comparable, and in some cases exceeds the magnitude of benefit of many of our very good standard medical therapies in oncology,” study presenter Christopher Booth, MD, with Queen’s University, Kingston, Ontario, Canada, told attendees.

Results of the study were published online in The New England Journal of Medicine to coincide with the presentation at the meeting.

The findings are “nothing short of a major milestone,” said study discussant Peter Campbell, PhD, with Montefiore Einstein Comprehensive Cancer Center, Bronx, New York.

The other study showed that eating a less inflammatory diet may reduce the risk for death in patients with colon cancer, with the greatest benefits seen in those who embraced anti-inflammatory foods and exercised regularly.

“Putting these two abstracts into perspective, we as physicians need to be essentially prescribing healthy diet and exercise. The combination of the two are synergistic,” Julie Gralow, MD, ASCO chief medical officer and executive vice president, told attendees.

Despite the benefits of these lifestyle changes, exercise and diet are meant to supplement, not replace, established colon cancer treatments.

It would be a false binary to frame this as lifestyle vs cancer treatment, explained Mark Lewis, MD, director of Gastrointestinal Oncology at Intermountain Healthcare in Salt Lake City, Utah. With exercise, for instance, “the key is giving enough chemo to protect against recurrence and eliminate micrometastases but not so much that we cause neuropathy and reduce function and ability to follow the CHALLENGE structured program,” Lewis said.

Exercise and Survival

Colon cancer remains the second-leading cause of cancer death worldwide. Even with surgery and chemotherapy, roughly 30% of patients with stage III and high-risk stage II colon cancer will experience disease recurrence.

“As oncologists, one of the most common questions we get asked by patients is — what else can I do to improve my outcome?” Booth said.

Observational studies published nearly two decades ago hinted that physically active cancer survivors fare better, but no randomized trial has definitively tested whether exercise could alter disease course. That knowledge gap prompted the Canadian Cancer Trials Group to launch the CHALLENGE trial.

Between 2009 and 2023, the phase 3 study enrolled 889 adults (median age, 61 years; 51% women) who had completed surgery and adjuvant chemotherapy for stage III (90%) or high-risk stage II (10%) colon cancer. Most patients were from Canada and Australia and were enrolled 2-6 months after completing chemotherapy.

Half of study participants were randomly allocated to a structured exercise program (n = 445) and half to receive standard health education materials promoting physical activity and healthy eating (control individuals, n = 444).

As part of the structured exercise intervention, patients met with a physical activity consultant twice a month for the first 6 months. These sessions included exercise coaching and supervised exercise. Patients could choose their preferred aerobic exercise and most picked brisk walking.

The consultants gave each patient an “exercise prescription” to hit a specific amount of exercise. The target was an additional 10 metabolic equivalent (MET)–hours of aerobic activity per week — about three to four brisk walks each lasting 45-60 minutes. After 6 months, patients met with their consultants once a month, with additional sessions available for extra support if needed.

Structured exercise led to “substantial and sustained” increases in the amount of exercise participants did, as well as physiologic measures of their fitness, with “highly relevant” improvements in VO₂ max, 6-minute walk test, and patient-reported physical function, underscoring that participants were not only exercising more but also getting fitter, Booth said.

Exercise was associated with a clinically meaningful and statistically significant 28% reduction in the risk for recurrent or new cancer (hazard ratio [HR], 0.72; P = .017), with a 5-year disease free survival rate of 80% in the exercise group and 74% in the control group.

In other words, “for every 16 patients that went on the exercise program, exercise prevented 1 person from recurrent or new cancer” at 5 years, Booth reported.

Overall survival results were “even more impressive,” he said.

At 8 years, 90% of patients in the exercise program were alive vs 83% of those in the control group, which translated to a 37% lower risk for death (HR, 0.63; P = .022).

“For every 14 patients who went on the exercise program, exercise prevented 1 person from dying” at the 8-year mark, Booth noted.

“Notably, this difference in survival was not driven by difference in cardiovascular deaths but by a reduction in the risk of death from colon cancer,” he said.

Besides a slight uptick in musculoskeletal aches, no major safety signals emerged in the exercise group.

It’s important to note that the survival benefit associated with exercise came after patients had received surgery followed by chemotherapy — in other words, exercise did not replace established cancer treatments. It’s also unclear whether initiating an exercise intervention earlier in the treatment trajectory — before surgery or during chemotherapy, instead of after chemotherapy — could further improve cancer outcomes, the authors noted.

Still, “exercise as an intervention is a no brainer and should be implemented broadly,” said ASCO expert Pamela Kunz, MD, with Yale School of Medicine, New Haven, Connecticut.

Marco Gerlinger, MD, with Barts Cancer Institute, London, England, agreed.

“Oncologists can now make a very clear evidence-based recommendation for patients who just completed their chemotherapy for bowel cancer and are fit enough for such an exercise program,” Gerlinger said in a statement from the nonprofit UK Science Media Centre.

Booth noted that knowledge alone will not be sufficient to allow most patients to change their lifestyle and realize the health benefits.

“The policy implementation piece of this is really key, and we need health systems, hospitals, and payers to invest in these behavior support programs so that patients have access to a physical activity consultant and can realize the health benefits,” he said.

“This intervention is empowering and achievable for patients and with much, much lower cost than many of our therapies. It is also sustainable for health systems,” he concluded.

Diet and Survival

Diet can also affect outcomes in patients with colon cancer.

In the same session describing the CHALLENGE results, Sara Char, MD, with Dana-Farber Cancer Institute in Boston, reported findings showing that consuming a diet high in proinflammatory foods was associated with worse overall survival in patients with stage III colon cancer. A proinflammatory diet includes red and processed meats, sugary drinks, and refined grains, while an anti-inflammatory diet focuses on fruits, vegetables, whole grains, fish, and olive oil.

Chronic systemic inflammation has been implicated in both colon cancer development and in its progression, and elevated levels of inflammatory markers in the blood have previously been associated with worse survival outcomes in patients with stage III colon cancer.

Char and colleagues analyzed dietary patterns of a subset of 1625 patients (mean age, 61 years) with resected stage III colon cancer enrolled in the phase 3 CALGB/SWOG 80702 (Alliance) clinical trial, which compared 3 months of adjuvant chemotherapy with 6 months of adjuvant chemotherapy, with or without the anti-inflammatory medication celecoxib.

As part of the trial, participants reported their diet and exercise habits at various timepoints. Their diets were scored using the validated empirical dietary inflammatory pattern (EDIP) tool, which is a weighted sum of 18 food groups — nine proinflammatory and nine anti-inflammatory. A high EDIP score marks a proinflammatory diet, and a low EDIP score indicates a less inflammatory diet.

During median follow-up of nearly 4 years, researchers noted a trend toward worse disease-free survival in patients with high proinflammatory diets (HR, 1.46), but this association was not significant in the multivariable adjusted model (HR, 1.36; P = .22), Char reported.

However, higher intake of proinflammatory foods was associated with significantly worse overall survival.

Patients who consumed the most proinflammatory foods (top 20%) had an 87% higher risk for death compared with those who consumed the least (bottom 20%; HR, 1.87). The median overall survival in the highest quintile was 7.7 years and was not reached in the lowest quintile.

Combine Exercise and Diet for Best Results

To examine the joint effect of physical activity and diet on overall survival, patients were divided into higher and lower levels of physical activity using a cut-off of 9 MET hours per week, which roughly correlates to 30 minutes of vigorous walking five days a week with a little bit of light yoga, Char explained.

In this analysis, patients with less proinflammatory diets and higher physical activity levels had the best overall survival outcomes, with a 63% lower risk for death compared with peers who consumed more pro-inflammatory diets and exercised less (HR, 0.37; P < .0001).

Daily celecoxib use and low-dose aspirin use (< 100 mg/d) did not affect the association between inflammatory diet and survival.

Char cautioned, that while the EDIP tool is useful to measure the inflammatory potential of a diet, “this is not a dietary recommendation, and we need further studies to be able to tailor our findings into dietary recommendations that can be provided to patients at the bedside.”

Gralow said this “early but promising observational study suggests a powerful synergy: Patients with stage III colon cancer who embraced anti-inflammatory foods and exercised regularly showed the best overall survival compared to those with inflammatory diets and limited exercise.”

The CHALLENGE trial was funded by the Canadian Cancer Society, the National Health and Medical Research Council, Cancer Research UK, and the University of Sydney Cancer Research Fund. Booth had no disclosures. The diet study was funded by the National Institutes of Health, Pfizer, and the Project P Fund. Char disclosed an advisory/consultant role with Goodpath. Kunz, Gralow and Campbell had no relevant disclosures.

A version of this article first appeared on Medscape.com.

SAN DIEGO — Low fermentable oligo-, di-, and monosaccharides and polyols (FODMAPs) dietary advice has been shown to be effective in easing bloating and abdominal pain, especially in patients with irritable bowel syndrome (IBS), but limited availability of dietitians makes delivering this advice challenging. Researchers from Thailand have successfully enlisted a chatbot to help.

In a randomized controlled trial, they found that chatbot-assisted dietary advice with brief guidance effectively reduced high FODMAP intake, bloating severity, and improved dietary knowledge, particularly in patients with bothersome bloating.

“Chatbot-assisted dietary advice for FODMAPs restriction was feasible and applicable in patients with bloating symptoms that had baseline symptoms of moderate severity,” study chief Pochara Somvanapanich, with the Division of Gastroenterology, Chulalongkorn University and King Chulalongkorn Memorial Hospital, Bangkok, Thailand, told GI & Hepatology News.

Somvanapanich, who developed the chatbot algorithm, presented the study results at Digestive Disease Week (DDW) 2025.

More Knowledge, Less Bloating

The trial enrolled 86 adults with disorders of gut-brain interaction experiencing bloating symptoms for more than 6 months and consuming more than seven high-FODMAPs items per week. Half of them had IBS.

At baseline, gastrointestinal (GI) symptoms and the ability to identify FODMAPs were assessed. All participants received a 5-minute consultation on FODMAPs avoidance from a GI fellow and were randomly allocated (stratified by IBS diagnosis and education) into two groups.

The chatbot-assisted group received real-time dietary advice via a chatbot which helped them identify high, low, and non-FODMAP foods from a list of more than 300 ingredients/dishes of Thai and western cuisines.

The control group received only brief advice on high FODMAPs restriction. Both groups used a diary app to log food intake and postprandial symptoms. Baseline bloating, abdominal pain and global symptoms severity were similar between the two groups. Data on 64 participants (32 in each group) were analyzed.

After 4 weeks, significantly more people in the chatbot group than the control group responded — achieving a 30% or greater reduction in daily worst bloating, abdominal pain or global symptoms (19 [59%] vs 10 [31%], P < .05). Responder rates were similar in the IBS and non-IBS subgroups.

Subgroup analysis revealed significant differences between groups only for participants with bothersome bloating, not those with mild bloating severity.

In those with bothersome bloating severity, the chatbot group had a higher response rate (69.5% vs 36.3%) and fewer bloating symptoms (P < .05). They also had a greater reduction in high FODMAPs intake (10 vs 23 items/week) and demonstrated improved knowledge in identifying FODMAPs (P < .05).

“Responders in a chatbot group consistently engaged more with the app, performing significantly more weekly item searches than nonresponders (P < .05),” the authors noted in their conference abstract.

“Our next step is to develop the chatbot-assisted approach for the reintroduction and personalization phase based on messenger applications (including Facebook Messenger and other messaging platforms),” Somvanapanich told GI & Hepatology News.

“Once we’ve gathered enough data to confirm these are working effectively, we definitely plan to create a one-stop service application for FODMAPs dietary advice,” Somvanapanich added.

Lack of Robust Data on Digital GI Health Apps

Commenting on this research for GI & Hepatology News, Sidhartha R. Sinha, MD, Director of Digital Health and Innovation, Division of Gastroenterology and Hepatology, Stanford University in Stanford, California, noted that there is a “notable lack of robust data supporting digital health tools in gastroenterology. Despite hundreds of apps available, very few are supported by well-designed trials.”

“The study demonstrated that chatbot-assisted dietary advice significantly improved bloating symptoms, reduced intake of high-FODMAP foods, and enhanced patients’ dietary knowledge compared to brief dietary counseling alone, especially in those with bothersome symptoms,” said Sinha, who wasn’t involved in the study.

“Patients actively used the chatbot to manage their symptoms, achieving a higher response rate than those in the control arm who received brief counseling on avoiding high-FODMAP food,” he noted.

Sinha said in his practice at Stanford, “in the heart of Silicon Valley,” patients do use digital resources to manage their GI symptoms, including diseases like IBS and inflammatory bowel disease (IBD) — and he believes this is “increasingly common nationally.”

“However, the need for evidence-based tools is critical and the lack here often prevents many practitioners from regularly recommending them to patients. This study aligns well with clinical practice, and supports the use of this particular app to improve IBS symptoms, particularly when access to dietitians is limited. These results support chatbot-assisted dietary management as a feasible, effective, and scalable approach to patient care,” Sinha told GI & Hepatology News.

The study received no commercial funding. Somvanapanich and Sinha had no relevant disclosures.

A version of this article appeared on Medscape.com.
 

SAN DIEGO — Low fermentable oligo-, di-, and monosaccharides and polyols (FODMAPs) dietary advice has been shown to be effective in easing bloating and abdominal pain, especially in patients with irritable bowel syndrome (IBS), but limited availability of dietitians makes delivering this advice challenging. Researchers from Thailand have successfully enlisted a chatbot to help.

In a randomized controlled trial, they found that chatbot-assisted dietary advice with brief guidance effectively reduced high FODMAP intake, bloating severity, and improved dietary knowledge, particularly in patients with bothersome bloating.

“Chatbot-assisted dietary advice for FODMAPs restriction was feasible and applicable in patients with bloating symptoms that had baseline symptoms of moderate severity,” study chief Pochara Somvanapanich, with the Division of Gastroenterology, Chulalongkorn University and King Chulalongkorn Memorial Hospital, Bangkok, Thailand, told GI & Hepatology News.

Somvanapanich, who developed the chatbot algorithm, presented the study results at Digestive Disease Week (DDW) 2025.

More Knowledge, Less Bloating

The trial enrolled 86 adults with disorders of gut-brain interaction experiencing bloating symptoms for more than 6 months and consuming more than seven high-FODMAPs items per week. Half of them had IBS.

At baseline, gastrointestinal (GI) symptoms and the ability to identify FODMAPs were assessed. All participants received a 5-minute consultation on FODMAPs avoidance from a GI fellow and were randomly allocated (stratified by IBS diagnosis and education) into two groups.

The chatbot-assisted group received real-time dietary advice via a chatbot which helped them identify high, low, and non-FODMAP foods from a list of more than 300 ingredients/dishes of Thai and western cuisines.

The control group received only brief advice on high FODMAPs restriction. Both groups used a diary app to log food intake and postprandial symptoms. Baseline bloating, abdominal pain and global symptoms severity were similar between the two groups. Data on 64 participants (32 in each group) were analyzed.

After 4 weeks, significantly more people in the chatbot group than the control group responded — achieving a 30% or greater reduction in daily worst bloating, abdominal pain or global symptoms (19 [59%] vs 10 [31%], P < .05). Responder rates were similar in the IBS and non-IBS subgroups.

Subgroup analysis revealed significant differences between groups only for participants with bothersome bloating, not those with mild bloating severity.

In those with bothersome bloating severity, the chatbot group had a higher response rate (69.5% vs 36.3%) and fewer bloating symptoms (P < .05). They also had a greater reduction in high FODMAPs intake (10 vs 23 items/week) and demonstrated improved knowledge in identifying FODMAPs (P < .05).

“Responders in a chatbot group consistently engaged more with the app, performing significantly more weekly item searches than nonresponders (P < .05),” the authors noted in their conference abstract.

“Our next step is to develop the chatbot-assisted approach for the reintroduction and personalization phase based on messenger applications (including Facebook Messenger and other messaging platforms),” Somvanapanich told GI & Hepatology News.

“Once we’ve gathered enough data to confirm these are working effectively, we definitely plan to create a one-stop service application for FODMAPs dietary advice,” Somvanapanich added.

Lack of Robust Data on Digital GI Health Apps

Commenting on this research for GI & Hepatology News, Sidhartha R. Sinha, MD, Director of Digital Health and Innovation, Division of Gastroenterology and Hepatology, Stanford University in Stanford, California, noted that there is a “notable lack of robust data supporting digital health tools in gastroenterology. Despite hundreds of apps available, very few are supported by well-designed trials.”

“The study demonstrated that chatbot-assisted dietary advice significantly improved bloating symptoms, reduced intake of high-FODMAP foods, and enhanced patients’ dietary knowledge compared to brief dietary counseling alone, especially in those with bothersome symptoms,” said Sinha, who wasn’t involved in the study.

“Patients actively used the chatbot to manage their symptoms, achieving a higher response rate than those in the control arm who received brief counseling on avoiding high-FODMAP food,” he noted.

Sinha said in his practice at Stanford, “in the heart of Silicon Valley,” patients do use digital resources to manage their GI symptoms, including diseases like IBS and inflammatory bowel disease (IBD) — and he believes this is “increasingly common nationally.”

“However, the need for evidence-based tools is critical and the lack here often prevents many practitioners from regularly recommending them to patients. This study aligns well with clinical practice, and supports the use of this particular app to improve IBS symptoms, particularly when access to dietitians is limited. These results support chatbot-assisted dietary management as a feasible, effective, and scalable approach to patient care,” Sinha told GI & Hepatology News.

The study received no commercial funding. Somvanapanich and Sinha had no relevant disclosures.

A version of this article appeared on Medscape.com.
 

SAN DIEGO — Low fermentable oligo-, di-, and monosaccharides and polyols (FODMAPs) dietary advice has been shown to be effective in easing bloating and abdominal pain, especially in patients with irritable bowel syndrome (IBS), but limited availability of dietitians makes delivering this advice challenging. Researchers from Thailand have successfully enlisted a chatbot to help.

In a randomized controlled trial, they found that chatbot-assisted dietary advice with brief guidance effectively reduced high FODMAP intake, bloating severity, and improved dietary knowledge, particularly in patients with bothersome bloating.

“Chatbot-assisted dietary advice for FODMAPs restriction was feasible and applicable in patients with bloating symptoms that had baseline symptoms of moderate severity,” study chief Pochara Somvanapanich, with the Division of Gastroenterology, Chulalongkorn University and King Chulalongkorn Memorial Hospital, Bangkok, Thailand, told GI & Hepatology News.

Somvanapanich, who developed the chatbot algorithm, presented the study results at Digestive Disease Week (DDW) 2025.

More Knowledge, Less Bloating

The trial enrolled 86 adults with disorders of gut-brain interaction experiencing bloating symptoms for more than 6 months and consuming more than seven high-FODMAPs items per week. Half of them had IBS.

At baseline, gastrointestinal (GI) symptoms and the ability to identify FODMAPs were assessed. All participants received a 5-minute consultation on FODMAPs avoidance from a GI fellow and were randomly allocated (stratified by IBS diagnosis and education) into two groups.

The chatbot-assisted group received real-time dietary advice via a chatbot which helped them identify high, low, and non-FODMAP foods from a list of more than 300 ingredients/dishes of Thai and western cuisines.

The control group received only brief advice on high FODMAPs restriction. Both groups used a diary app to log food intake and postprandial symptoms. Baseline bloating, abdominal pain and global symptoms severity were similar between the two groups. Data on 64 participants (32 in each group) were analyzed.

After 4 weeks, significantly more people in the chatbot group than the control group responded — achieving a 30% or greater reduction in daily worst bloating, abdominal pain or global symptoms (19 [59%] vs 10 [31%], P < .05). Responder rates were similar in the IBS and non-IBS subgroups.

Subgroup analysis revealed significant differences between groups only for participants with bothersome bloating, not those with mild bloating severity.

In those with bothersome bloating severity, the chatbot group had a higher response rate (69.5% vs 36.3%) and fewer bloating symptoms (P < .05). They also had a greater reduction in high FODMAPs intake (10 vs 23 items/week) and demonstrated improved knowledge in identifying FODMAPs (P < .05).

“Responders in a chatbot group consistently engaged more with the app, performing significantly more weekly item searches than nonresponders (P < .05),” the authors noted in their conference abstract.

“Our next step is to develop the chatbot-assisted approach for the reintroduction and personalization phase based on messenger applications (including Facebook Messenger and other messaging platforms),” Somvanapanich told GI & Hepatology News.

“Once we’ve gathered enough data to confirm these are working effectively, we definitely plan to create a one-stop service application for FODMAPs dietary advice,” Somvanapanich added.

Lack of Robust Data on Digital GI Health Apps

Commenting on this research for GI & Hepatology News, Sidhartha R. Sinha, MD, Director of Digital Health and Innovation, Division of Gastroenterology and Hepatology, Stanford University in Stanford, California, noted that there is a “notable lack of robust data supporting digital health tools in gastroenterology. Despite hundreds of apps available, very few are supported by well-designed trials.”

“The study demonstrated that chatbot-assisted dietary advice significantly improved bloating symptoms, reduced intake of high-FODMAP foods, and enhanced patients’ dietary knowledge compared to brief dietary counseling alone, especially in those with bothersome symptoms,” said Sinha, who wasn’t involved in the study.

“Patients actively used the chatbot to manage their symptoms, achieving a higher response rate than those in the control arm who received brief counseling on avoiding high-FODMAP food,” he noted.

Sinha said in his practice at Stanford, “in the heart of Silicon Valley,” patients do use digital resources to manage their GI symptoms, including diseases like IBS and inflammatory bowel disease (IBD) — and he believes this is “increasingly common nationally.”

“However, the need for evidence-based tools is critical and the lack here often prevents many practitioners from regularly recommending them to patients. This study aligns well with clinical practice, and supports the use of this particular app to improve IBS symptoms, particularly when access to dietitians is limited. These results support chatbot-assisted dietary management as a feasible, effective, and scalable approach to patient care,” Sinha told GI & Hepatology News.

The study received no commercial funding. Somvanapanich and Sinha had no relevant disclosures.

A version of this article appeared on Medscape.com.
 

SAN DIEGO — A real-time, blood-sensing capsule (PillSense) is a safe and effective diagnostic tool for patients with suspected upper gastrointestinal (GI) bleeding that can aid patient triage, reduce unnecessary procedures, and optimize resource use, a study found.

Notably, patients with negative capsule results had shorter hospital stays and lower acuity markers, and in more than one third of cases, an esophagogastroduodenoscopy (EGD) was avoided altogether without any observed adverse events or readmissions, the study team found.

“Our study shows that this novel capsule that detects blood in the upper GI tract (PillSense) was highly sensitive and specific (> 90%) for detecting recent or active upper GI blood, influenced clinical management in 80% of cases and allowed about one third of patients to be safely discharged from the emergency department, with close outpatient follow-up,” Linda Lee, MD, AGAF, medical director of endoscopy, Brigham and Women’s Hospital and associate professor of medicine, Harvard Medical School, Boston, told GI & Hepatology News.

The study was presented at Digestive Disease Week^® (DDW) 2025.

 

Real-World Insights

EGD is the gold standard for diagnosing suspected upper GI bleeding, but limited access to timely EGD complicates diagnosis and resource allocation.

Approved by the US Food and Drug Administration, PillSense (EnteraSense) is an ingestible capsule with a reusable receiver that provides a rapid, noninvasive method for detecting upper GI bleeding. The capsule analyzes light absorption to identify blood and transmits the result within 10 minutes.

Lee and colleagues evaluated the real-world impact of this point-of-care device on clinical triage and resource allocation, while assessing its safety profile.

They analyzed data on 43 patients (mean age 60 years; 72% men) with clinical suspicion of upper GI bleeding in whom the device was used. The most common symptoms were symptomatic anemia (70%), melena (67%), and hematemesis (33%).

Sixteen PillSense studies (37%) were positive for blood detection, and 27 (63%) were negative.

Compared to patients with a positive capsule results, those without blood detected by the capsule had shorter hospital stays (mean, 3.8 vs 13.4 days, P = .02), lower GBS scores (mean, 7.93 vs 12.81; P = .005), and fewer units of blood transfused (mean, 1.19 vs 10.94; P = .01) and were less apt to be hemodynamically unstable (5 vs 8 patients; P = .03).

Capsule results influenced clinical management in 80% of cases, leading to avoidance of EGD in 37% and prioritization of urgent EGD in 18% (all had active bleeding on EGD).

Capsule use improved resource allocation in 51% of cases. This included 12 patients who were discharged from the ED, six who were assigned an inpatient bed early, and four who underwent expedited colonoscopy as upper GI bleeding was ruled out, they noted.

Among the eight patients who did not undergo EGD, there were no readmissions within 30 days and no adverse events. There were no capsule-related adverse events.

“Clinicians should consider using this novel capsule PillSense as another data point in the management of suspected upper GI bleed,” Lee told GI & Hepatology News.

“This could include in helping to triage patients for safe discharge from the ED or to more urgent endoscopy, to differentiate between upper vs lower GI bleed and to manage ICU patients with possible rebleeding,” Lee said.

 

Important Real-World Evidence

Reached for comment, Shahin Ayazi, MD, esophageal surgeon, Director, Allegheny Health Network Chevalier Jackson Esophageal Research Center, Pittsburgh, Pennsylvania, said this study is important for several reasons.

“Prior investigations have established that PillSense possesses a high negative predictive value for detecting upper GI bleeding and have speculated on its utility in triage, decision-making, and potentially avoiding unnecessary endoscopy. This study is important because it substantiates that speculation with clinical data,” Ayazi, who wasn’t involved in the study, told GI & Hepatology News.

“These findings support the capsule’s practical application in patient stratification and clinical workflow, particularly when diagnostic uncertainty is high and endoscopic resources are limited,” Ayazi noted.

In his experience, PillSense is “highly useful as a triage adjunct in the evaluation of suspected upper GI bleeding. It provides direct and objective evidence as to whether blood is currently present in the stomach,” he said.

“In patients whose presentation is ambiguous or whose clinical scores fall into an intermediate risk zone, this binary result can provide clarity that subjective assessment alone may not achieve. This is particularly relevant in settings where the goal is to perform endoscopy within 24 hours, but the volume of consults exceeds procedural capacity,” Ayazi explained.

“In such scenarios, PillSense enables physicians to stratify patients based on objective evidence of active bleeding, helping to prioritize those who require urgent endoscopy and defer or even avoid endoscopic evaluation in those who do not. The result is a more efficient allocation of endoscopic resources without compromising patient safety,” he added.

Ayazi cautioned that the PillSense capsule should not be used as a replacement for clinical evaluation or established risk stratification protocols.

“It is intended for hemodynamically stable patients and has not been validated in cases of active or massive bleeding. Its diagnostic yield depends on the presence of blood in the stomach at the time of capsule transit; intermittent or proximal bleeding that has ceased may not be detected, introducing the potential for false-negative results,” Ayazi told GI & Hepatology News.

“However, in prior studies, the negative predictive value was high, and in the present study, no adverse outcomes were observed in patients who did not undergo endoscopy following a negative PillSense result,” Ayazi noted.

“It must also be understood that PillSense does not localize the source of bleeding or replace endoscopy in patients with a high likelihood of active hemorrhage. It is not designed to detect bleeding from the lower GI tract or distal small bowel. Rather, it serves as an adjunct that can provide immediate clarity when the need for endoscopy is uncertain, and should be interpreted within the broader context of clinical findings, laboratory data, and established risk stratification tools,” he added.

The study had no specific funding. Lee and Ayazi had no relevant disclosures.

A version of this article appeared on Medscape.com.

SAN DIEGO — A real-time, blood-sensing capsule (PillSense) is a safe and effective diagnostic tool for patients with suspected upper gastrointestinal (GI) bleeding that can aid patient triage, reduce unnecessary procedures, and optimize resource use, a study found.

Notably, patients with negative capsule results had shorter hospital stays and lower acuity markers, and in more than one third of cases, an esophagogastroduodenoscopy (EGD) was avoided altogether without any observed adverse events or readmissions, the study team found.

“Our study shows that this novel capsule that detects blood in the upper GI tract (PillSense) was highly sensitive and specific (> 90%) for detecting recent or active upper GI blood, influenced clinical management in 80% of cases and allowed about one third of patients to be safely discharged from the emergency department, with close outpatient follow-up,” Linda Lee, MD, AGAF, medical director of endoscopy, Brigham and Women’s Hospital and associate professor of medicine, Harvard Medical School, Boston, told GI & Hepatology News.

The study was presented at Digestive Disease Week^® (DDW) 2025.

 

Real-World Insights

EGD is the gold standard for diagnosing suspected upper GI bleeding, but limited access to timely EGD complicates diagnosis and resource allocation.

Approved by the US Food and Drug Administration, PillSense (EnteraSense) is an ingestible capsule with a reusable receiver that provides a rapid, noninvasive method for detecting upper GI bleeding. The capsule analyzes light absorption to identify blood and transmits the result within 10 minutes.

Lee and colleagues evaluated the real-world impact of this point-of-care device on clinical triage and resource allocation, while assessing its safety profile.

They analyzed data on 43 patients (mean age 60 years; 72% men) with clinical suspicion of upper GI bleeding in whom the device was used. The most common symptoms were symptomatic anemia (70%), melena (67%), and hematemesis (33%).

Sixteen PillSense studies (37%) were positive for blood detection, and 27 (63%) were negative.

Compared to patients with a positive capsule results, those without blood detected by the capsule had shorter hospital stays (mean, 3.8 vs 13.4 days, P = .02), lower GBS scores (mean, 7.93 vs 12.81; P = .005), and fewer units of blood transfused (mean, 1.19 vs 10.94; P = .01) and were less apt to be hemodynamically unstable (5 vs 8 patients; P = .03).

Capsule results influenced clinical management in 80% of cases, leading to avoidance of EGD in 37% and prioritization of urgent EGD in 18% (all had active bleeding on EGD).

Capsule use improved resource allocation in 51% of cases. This included 12 patients who were discharged from the ED, six who were assigned an inpatient bed early, and four who underwent expedited colonoscopy as upper GI bleeding was ruled out, they noted.

Among the eight patients who did not undergo EGD, there were no readmissions within 30 days and no adverse events. There were no capsule-related adverse events.

“Clinicians should consider using this novel capsule PillSense as another data point in the management of suspected upper GI bleed,” Lee told GI & Hepatology News.

“This could include in helping to triage patients for safe discharge from the ED or to more urgent endoscopy, to differentiate between upper vs lower GI bleed and to manage ICU patients with possible rebleeding,” Lee said.

 

Important Real-World Evidence

Reached for comment, Shahin Ayazi, MD, esophageal surgeon, Director, Allegheny Health Network Chevalier Jackson Esophageal Research Center, Pittsburgh, Pennsylvania, said this study is important for several reasons.

“Prior investigations have established that PillSense possesses a high negative predictive value for detecting upper GI bleeding and have speculated on its utility in triage, decision-making, and potentially avoiding unnecessary endoscopy. This study is important because it substantiates that speculation with clinical data,” Ayazi, who wasn’t involved in the study, told GI & Hepatology News.

“These findings support the capsule’s practical application in patient stratification and clinical workflow, particularly when diagnostic uncertainty is high and endoscopic resources are limited,” Ayazi noted.

In his experience, PillSense is “highly useful as a triage adjunct in the evaluation of suspected upper GI bleeding. It provides direct and objective evidence as to whether blood is currently present in the stomach,” he said.

“In patients whose presentation is ambiguous or whose clinical scores fall into an intermediate risk zone, this binary result can provide clarity that subjective assessment alone may not achieve. This is particularly relevant in settings where the goal is to perform endoscopy within 24 hours, but the volume of consults exceeds procedural capacity,” Ayazi explained.

“In such scenarios, PillSense enables physicians to stratify patients based on objective evidence of active bleeding, helping to prioritize those who require urgent endoscopy and defer or even avoid endoscopic evaluation in those who do not. The result is a more efficient allocation of endoscopic resources without compromising patient safety,” he added.

Ayazi cautioned that the PillSense capsule should not be used as a replacement for clinical evaluation or established risk stratification protocols.

“It is intended for hemodynamically stable patients and has not been validated in cases of active or massive bleeding. Its diagnostic yield depends on the presence of blood in the stomach at the time of capsule transit; intermittent or proximal bleeding that has ceased may not be detected, introducing the potential for false-negative results,” Ayazi told GI & Hepatology News.

“However, in prior studies, the negative predictive value was high, and in the present study, no adverse outcomes were observed in patients who did not undergo endoscopy following a negative PillSense result,” Ayazi noted.

“It must also be understood that PillSense does not localize the source of bleeding or replace endoscopy in patients with a high likelihood of active hemorrhage. It is not designed to detect bleeding from the lower GI tract or distal small bowel. Rather, it serves as an adjunct that can provide immediate clarity when the need for endoscopy is uncertain, and should be interpreted within the broader context of clinical findings, laboratory data, and established risk stratification tools,” he added.

The study had no specific funding. Lee and Ayazi had no relevant disclosures.

A version of this article appeared on Medscape.com.

SAN DIEGO — A real-time, blood-sensing capsule (PillSense) is a safe and effective diagnostic tool for patients with suspected upper gastrointestinal (GI) bleeding that can aid patient triage, reduce unnecessary procedures, and optimize resource use, a study found.

Notably, patients with negative capsule results had shorter hospital stays and lower acuity markers, and in more than one third of cases, an esophagogastroduodenoscopy (EGD) was avoided altogether without any observed adverse events or readmissions, the study team found.

“Our study shows that this novel capsule that detects blood in the upper GI tract (PillSense) was highly sensitive and specific (> 90%) for detecting recent or active upper GI blood, influenced clinical management in 80% of cases and allowed about one third of patients to be safely discharged from the emergency department, with close outpatient follow-up,” Linda Lee, MD, AGAF, medical director of endoscopy, Brigham and Women’s Hospital and associate professor of medicine, Harvard Medical School, Boston, told GI & Hepatology News.

The study was presented at Digestive Disease Week^® (DDW) 2025.

 

Real-World Insights

EGD is the gold standard for diagnosing suspected upper GI bleeding, but limited access to timely EGD complicates diagnosis and resource allocation.

Approved by the US Food and Drug Administration, PillSense (EnteraSense) is an ingestible capsule with a reusable receiver that provides a rapid, noninvasive method for detecting upper GI bleeding. The capsule analyzes light absorption to identify blood and transmits the result within 10 minutes.

Lee and colleagues evaluated the real-world impact of this point-of-care device on clinical triage and resource allocation, while assessing its safety profile.

They analyzed data on 43 patients (mean age 60 years; 72% men) with clinical suspicion of upper GI bleeding in whom the device was used. The most common symptoms were symptomatic anemia (70%), melena (67%), and hematemesis (33%).

Sixteen PillSense studies (37%) were positive for blood detection, and 27 (63%) were negative.

Compared to patients with a positive capsule results, those without blood detected by the capsule had shorter hospital stays (mean, 3.8 vs 13.4 days, P = .02), lower GBS scores (mean, 7.93 vs 12.81; P = .005), and fewer units of blood transfused (mean, 1.19 vs 10.94; P = .01) and were less apt to be hemodynamically unstable (5 vs 8 patients; P = .03).

Capsule results influenced clinical management in 80% of cases, leading to avoidance of EGD in 37% and prioritization of urgent EGD in 18% (all had active bleeding on EGD).

Capsule use improved resource allocation in 51% of cases. This included 12 patients who were discharged from the ED, six who were assigned an inpatient bed early, and four who underwent expedited colonoscopy as upper GI bleeding was ruled out, they noted.

Among the eight patients who did not undergo EGD, there were no readmissions within 30 days and no adverse events. There were no capsule-related adverse events.

“Clinicians should consider using this novel capsule PillSense as another data point in the management of suspected upper GI bleed,” Lee told GI & Hepatology News.

“This could include in helping to triage patients for safe discharge from the ED or to more urgent endoscopy, to differentiate between upper vs lower GI bleed and to manage ICU patients with possible rebleeding,” Lee said.

 

Important Real-World Evidence

Reached for comment, Shahin Ayazi, MD, esophageal surgeon, Director, Allegheny Health Network Chevalier Jackson Esophageal Research Center, Pittsburgh, Pennsylvania, said this study is important for several reasons.

“Prior investigations have established that PillSense possesses a high negative predictive value for detecting upper GI bleeding and have speculated on its utility in triage, decision-making, and potentially avoiding unnecessary endoscopy. This study is important because it substantiates that speculation with clinical data,” Ayazi, who wasn’t involved in the study, told GI & Hepatology News.

“These findings support the capsule’s practical application in patient stratification and clinical workflow, particularly when diagnostic uncertainty is high and endoscopic resources are limited,” Ayazi noted.

In his experience, PillSense is “highly useful as a triage adjunct in the evaluation of suspected upper GI bleeding. It provides direct and objective evidence as to whether blood is currently present in the stomach,” he said.

“In patients whose presentation is ambiguous or whose clinical scores fall into an intermediate risk zone, this binary result can provide clarity that subjective assessment alone may not achieve. This is particularly relevant in settings where the goal is to perform endoscopy within 24 hours, but the volume of consults exceeds procedural capacity,” Ayazi explained.

“In such scenarios, PillSense enables physicians to stratify patients based on objective evidence of active bleeding, helping to prioritize those who require urgent endoscopy and defer or even avoid endoscopic evaluation in those who do not. The result is a more efficient allocation of endoscopic resources without compromising patient safety,” he added.

Ayazi cautioned that the PillSense capsule should not be used as a replacement for clinical evaluation or established risk stratification protocols.

“It is intended for hemodynamically stable patients and has not been validated in cases of active or massive bleeding. Its diagnostic yield depends on the presence of blood in the stomach at the time of capsule transit; intermittent or proximal bleeding that has ceased may not be detected, introducing the potential for false-negative results,” Ayazi told GI & Hepatology News.

“However, in prior studies, the negative predictive value was high, and in the present study, no adverse outcomes were observed in patients who did not undergo endoscopy following a negative PillSense result,” Ayazi noted.

“It must also be understood that PillSense does not localize the source of bleeding or replace endoscopy in patients with a high likelihood of active hemorrhage. It is not designed to detect bleeding from the lower GI tract or distal small bowel. Rather, it serves as an adjunct that can provide immediate clarity when the need for endoscopy is uncertain, and should be interpreted within the broader context of clinical findings, laboratory data, and established risk stratification tools,” he added.

The study had no specific funding. Lee and Ayazi had no relevant disclosures.

A version of this article appeared on Medscape.com.

SAN DIEGO – Advanced practice providers (APPs) can be trained to perform transnasal endoscopy (TNE) with a single-use ultra-slim gastroscope with only topical anesthesia, a pilot study showed.

“Our study showed that TNE can be performed safely by APPs, is well tolerated by patients, and significantly impacted patient management,” Whitney Kucher, PA-C, with Northwestern Medicine, Chicago, told GI & Hepatology News.

“The chief benefit of having APPs perform TNEs is increasing patient access and expediting management of upper GI [gastrointestinal] symptoms in patients,” said Kucher who presented the study at Digestive Disease Week® (DDW) 2025.

The EvoEndo single-use endoscopy system received 510(k) clearance from the US Food and Drug Administration in early 2022.

The system includes a sterile, single-use, flexible gastroscope designed for unsedated transnasal upper endoscopy and a small portable video controller.

Unsedated TNE can be used to evaluate and diagnose a wide range of upper GI conditions that may require frequent monitoring, including eosinophilic esophagitis (EoE), dysphagia, celiac disease, gastroesophageal reflux disease (GERD), Barrett’s esophagus (BE), malabsorption, and abdominal pain.

Kucher and colleagues assessed the ability for APPs to use the EvoEndo system to perform safe and accurate esophageal assessment using in-office TNE, following training.

TNE training lasted about 4 weeks and consisted of a stepwise approach involving lectures, simulation-based training, and hands-on supervised TNEs (10 per APP).

Once training was completed, and after providing consent, 25 patients were enrolled to undergo supervised TNE by an APP. Their mean age was 55 years, and 58% were women.

Indications for TNE were uncontrolled GERD symptoms in 12 patients, history of EoE in six patients, high-risk screening for BE in five patients, and dysphagia in two patients.

Technical success was achieved in all but one patient (96%), and there were no adverse events.

All 25 patients completed the procedure, with 17 (72%) giving it a TNEase score of 1 (with ease/no discomfort) or 2 (mild/occasional discomfort). Only two patients reported a score of 4 (very uncomfortable) but still completed the exam.

The average TNE procedure time was 7.3 minutes.

TNE findings changed management in 23 of 25 (92%) patients. The test led to a change in proton pump inhibitor dosing or interval in 14 patients (56%). Esophagogastroduodenoscopy (EGD) interval was extended in five patients (20%) and scheduled sooner in three patients (12%). Two patients (8%) had no change in management.

The study team said more data are needed in terms of learning curves, competency metrics, and health economics before widespread adoption can be supported.

“We are working on developing a standardized training plan so we can train more GI APPs in our department. We have plans to start an APP-driven TNE program in the coming months,” Kucher told GI & Hepatology News.

 

Caveats and Cautionary Notes

Commenting on this study for GI & Hepatology News, Amitabh Chak, MD, professor of medicine and oncology at Case Western Reserve University School of Medicine and University Hospitals Cleveland Medical Center, both in Cleveland, noted that the results are “similar to older studies where TNE appeared quite promising and APPs could be trained. There have been previous studies that APPs can perform colonoscopies and EGDs.”

Chak cautioned that previous studies showed that it took at least 50 supervised examinations for APPs to achieve the needed skills.

“Intubation transnasally can be painful for patients if not done with skill. Cognitive skills take longer. The gastroesophageal junction is dynamic, and recognition of subtle pathology takes training,” Chak noted.

“TNE has been around at least two decades. The challenge with uptake of TNE for Barrett’s screening has been acceptance by primary care physicians, patients and payers,” Chak told GI & Hepatology News.

The study had no specific funding. Kucher reported having no relevant disclosures. Chak reported having relationships with US Endoscopy, Lucid Diagnostics, Steris Endoscopy/US Endoscopy, Microtek, and Interpace Diagnostics.

A version of this article appeared on Medscape.com.

SAN DIEGO – Advanced practice providers (APPs) can be trained to perform transnasal endoscopy (TNE) with a single-use ultra-slim gastroscope with only topical anesthesia, a pilot study showed.

“Our study showed that TNE can be performed safely by APPs, is well tolerated by patients, and significantly impacted patient management,” Whitney Kucher, PA-C, with Northwestern Medicine, Chicago, told GI & Hepatology News.

“The chief benefit of having APPs perform TNEs is increasing patient access and expediting management of upper GI [gastrointestinal] symptoms in patients,” said Kucher who presented the study at Digestive Disease Week® (DDW) 2025.

The EvoEndo single-use endoscopy system received 510(k) clearance from the US Food and Drug Administration in early 2022.

The system includes a sterile, single-use, flexible gastroscope designed for unsedated transnasal upper endoscopy and a small portable video controller.

Unsedated TNE can be used to evaluate and diagnose a wide range of upper GI conditions that may require frequent monitoring, including eosinophilic esophagitis (EoE), dysphagia, celiac disease, gastroesophageal reflux disease (GERD), Barrett’s esophagus (BE), malabsorption, and abdominal pain.

Kucher and colleagues assessed the ability for APPs to use the EvoEndo system to perform safe and accurate esophageal assessment using in-office TNE, following training.

TNE training lasted about 4 weeks and consisted of a stepwise approach involving lectures, simulation-based training, and hands-on supervised TNEs (10 per APP).

Once training was completed, and after providing consent, 25 patients were enrolled to undergo supervised TNE by an APP. Their mean age was 55 years, and 58% were women.

Indications for TNE were uncontrolled GERD symptoms in 12 patients, history of EoE in six patients, high-risk screening for BE in five patients, and dysphagia in two patients.

Technical success was achieved in all but one patient (96%), and there were no adverse events.

All 25 patients completed the procedure, with 17 (72%) giving it a TNEase score of 1 (with ease/no discomfort) or 2 (mild/occasional discomfort). Only two patients reported a score of 4 (very uncomfortable) but still completed the exam.

The average TNE procedure time was 7.3 minutes.

TNE findings changed management in 23 of 25 (92%) patients. The test led to a change in proton pump inhibitor dosing or interval in 14 patients (56%). Esophagogastroduodenoscopy (EGD) interval was extended in five patients (20%) and scheduled sooner in three patients (12%). Two patients (8%) had no change in management.

The study team said more data are needed in terms of learning curves, competency metrics, and health economics before widespread adoption can be supported.

“We are working on developing a standardized training plan so we can train more GI APPs in our department. We have plans to start an APP-driven TNE program in the coming months,” Kucher told GI & Hepatology News.

 

Caveats and Cautionary Notes

Commenting on this study for GI & Hepatology News, Amitabh Chak, MD, professor of medicine and oncology at Case Western Reserve University School of Medicine and University Hospitals Cleveland Medical Center, both in Cleveland, noted that the results are “similar to older studies where TNE appeared quite promising and APPs could be trained. There have been previous studies that APPs can perform colonoscopies and EGDs.”

Chak cautioned that previous studies showed that it took at least 50 supervised examinations for APPs to achieve the needed skills.

“Intubation transnasally can be painful for patients if not done with skill. Cognitive skills take longer. The gastroesophageal junction is dynamic, and recognition of subtle pathology takes training,” Chak noted.

“TNE has been around at least two decades. The challenge with uptake of TNE for Barrett’s screening has been acceptance by primary care physicians, patients and payers,” Chak told GI & Hepatology News.

The study had no specific funding. Kucher reported having no relevant disclosures. Chak reported having relationships with US Endoscopy, Lucid Diagnostics, Steris Endoscopy/US Endoscopy, Microtek, and Interpace Diagnostics.

A version of this article appeared on Medscape.com.

SAN DIEGO – Advanced practice providers (APPs) can be trained to perform transnasal endoscopy (TNE) with a single-use ultra-slim gastroscope with only topical anesthesia, a pilot study showed.

“Our study showed that TNE can be performed safely by APPs, is well tolerated by patients, and significantly impacted patient management,” Whitney Kucher, PA-C, with Northwestern Medicine, Chicago, told GI & Hepatology News.

“The chief benefit of having APPs perform TNEs is increasing patient access and expediting management of upper GI [gastrointestinal] symptoms in patients,” said Kucher who presented the study at Digestive Disease Week® (DDW) 2025.

The EvoEndo single-use endoscopy system received 510(k) clearance from the US Food and Drug Administration in early 2022.

The system includes a sterile, single-use, flexible gastroscope designed for unsedated transnasal upper endoscopy and a small portable video controller.

Unsedated TNE can be used to evaluate and diagnose a wide range of upper GI conditions that may require frequent monitoring, including eosinophilic esophagitis (EoE), dysphagia, celiac disease, gastroesophageal reflux disease (GERD), Barrett’s esophagus (BE), malabsorption, and abdominal pain.

Kucher and colleagues assessed the ability for APPs to use the EvoEndo system to perform safe and accurate esophageal assessment using in-office TNE, following training.

TNE training lasted about 4 weeks and consisted of a stepwise approach involving lectures, simulation-based training, and hands-on supervised TNEs (10 per APP).

Once training was completed, and after providing consent, 25 patients were enrolled to undergo supervised TNE by an APP. Their mean age was 55 years, and 58% were women.

Indications for TNE were uncontrolled GERD symptoms in 12 patients, history of EoE in six patients, high-risk screening for BE in five patients, and dysphagia in two patients.

Technical success was achieved in all but one patient (96%), and there were no adverse events.

All 25 patients completed the procedure, with 17 (72%) giving it a TNEase score of 1 (with ease/no discomfort) or 2 (mild/occasional discomfort). Only two patients reported a score of 4 (very uncomfortable) but still completed the exam.

The average TNE procedure time was 7.3 minutes.

TNE findings changed management in 23 of 25 (92%) patients. The test led to a change in proton pump inhibitor dosing or interval in 14 patients (56%). Esophagogastroduodenoscopy (EGD) interval was extended in five patients (20%) and scheduled sooner in three patients (12%). Two patients (8%) had no change in management.

The study team said more data are needed in terms of learning curves, competency metrics, and health economics before widespread adoption can be supported.

“We are working on developing a standardized training plan so we can train more GI APPs in our department. We have plans to start an APP-driven TNE program in the coming months,” Kucher told GI & Hepatology News.

 

Caveats and Cautionary Notes

Commenting on this study for GI & Hepatology News, Amitabh Chak, MD, professor of medicine and oncology at Case Western Reserve University School of Medicine and University Hospitals Cleveland Medical Center, both in Cleveland, noted that the results are “similar to older studies where TNE appeared quite promising and APPs could be trained. There have been previous studies that APPs can perform colonoscopies and EGDs.”

Chak cautioned that previous studies showed that it took at least 50 supervised examinations for APPs to achieve the needed skills.

“Intubation transnasally can be painful for patients if not done with skill. Cognitive skills take longer. The gastroesophageal junction is dynamic, and recognition of subtle pathology takes training,” Chak noted.

“TNE has been around at least two decades. The challenge with uptake of TNE for Barrett’s screening has been acceptance by primary care physicians, patients and payers,” Chak told GI & Hepatology News.

The study had no specific funding. Kucher reported having no relevant disclosures. Chak reported having relationships with US Endoscopy, Lucid Diagnostics, Steris Endoscopy/US Endoscopy, Microtek, and Interpace Diagnostics.

A version of this article appeared on Medscape.com.

SAN DIEGO — An artificial intelligence (AI)–enhanced digital collaborative care model led to rapid, clinically significant, and sustained symptom relief for patients with irritable bowel syndrome (IBS) seen at Cleveland Clinic, Cleveland, Ohio, an observational study found.

Symptom tracking at 4-week intervals showed that “almost everybody got better” regardless of IBS subtype, with relief starting in the first 4 weeks, Stephen Lupe, PsyD, gastrointestinal psychologist and director of Behavioral Medicine, Department of Gastroenterology, Hepatology, and Nutrition at Cleveland Clinic, Cleveland, said in an interview with GI & Hepatology News.

The findings were presented at Digestive Disease Week (DDW) 2025.

 

Digital Boost to Collaborative Care Model

The combination of dietary interventions and brain-gut behavioral therapy has demonstrated excellent outcomes for patients with IBS, but patients struggle to access these needed services, Lupe noted. A medical home collaborative care model in which patients get care from a multidisciplinary team has been shown to be a good way to successfully deliver this combination of care.

“When you do collaborative in-person care, people get better quicker,” Lupe said.

However, scaling access to this model remains a challenge. For their study, Cleveland Clinic researchers added an AI-enhanced digital platform, Ayble Health, to the in-person collaborative care model to expand access to disease-management services and evaluated whether it improved clinical outcomes for study’s 171 participants, who were recruited via social media advertisements.

Here’s how the platform works. Once a patient enrolls in Ayble Health, a personalized care plan is recommended based on a virtual visit, screening questionnaire, and baseline survey.

The platform includes brain-gut programs, including guided audio content on mindfulness, hypnosis, meditation, cognitive behavioral therapy, and breathing techniques; personalized nutrition support to find and remove trigger foods, a food barcode scanner, and a comprehensive groceries database; and AI-powered wellness tools to help manage and track symptoms. Lupe worked with Ayble Health to develop the platform’s behavioral health content and care pathways.

Patients may choose to follow any combination of three care pathways: A care team overseen by gastro-psychologists, dietitians, and gastroenterologists; a holistic nutrition program including a personalized elimination diet; and a brain-gut behavioral therapy program with gut-directed hypnosis, cognitive behavioral therapy, and acceptance and commitment therapy. They go at their own pace, can connect with Ayble Health’s virtual care team to help with education and goal setting, and continue to consult their Cleveland Clinic providers as needed for evaluation and treatment.

“The care team is still there. We’ve just augmented it to make sure that as many people as possible get behavioral skills training and dietary support, with monitoring between visits — instead of the traditional, ‘I’ll see you in 6 months approach,” Lupe explained.

 

IBS Symptom Scores Improve

Of the study’s 171 patients, 20 had IBS-diarrhea, 23 had IBS-constipation, 32 had IBS-mixed, and 8 had IBS-unspecified. The remaining 88 patients reported IBS without indication of subtype.

At intake, all patients had active IBS symptoms, with scores ≥ 75 on the IBS symptom severity scale (IBS-SSS). Most patients enrolled in more than one care pathway, and 95% of participants completed at least 4 weeks on their chosen pathways.

Overall, patients saw an average 140-point decrease in IBS-SSS from intake through follow-up lasting up to 42 weeks. A drop in IBS-SSS score ≥ 50 points was considered a clinically meaningful change.

Symptom improvements occurred as early as week 4, were sustained and were uniform across IBS subtypes, suggesting that the AI-enhanced digital collaborative care model has wide utility in patients with IBS, Lupe said.

Patients with the most severe IBS symptoms showed the greatest improvement, but even 50% of those with mild symptoms had clinically meaningful changes in IBS-SSS.

Improvement in IBS symptoms was seen across all care pathways, but the combination of multiple pathways improved outcomes better than a single care pathway alone. The combination of nutrition and brain-gut behavioral therapy demonstrated the greatest reduction in IBS-SSS scores and proportion of patients achieving clinically meaningful results (95%).

The digital comprehensive car model for IBS is now “up and running” at Cleveland Clinic, and the team plans to proactively reach out to patients with gastrointestinal disorders recently seen at their center to alert them to the availability of this tool, Lupe said.

A randomized controlled trial is planned to further validate these observational findings, he added.

 

‘Wave of the Future’

The digital collaborative care model is “innovative, and I think is the wave of the future,” Kyle Staller, MD, MPH, gastroenterologist and director of the Gastrointestinal Motility Laboratory at Massachusetts General Hospital, Boston, who wasn’t involved in the study, told GI & Hepatology News.

“These digital platforms bundle nondrug options, such as cognitive-behavioral therapy, dietary therapy, hypnotherapy, so patients can choose what suits them, rather than the gastroenterologist hunting down each individual resource, which requires a lot of work,” Staller said.

The study “provides real-world evidence that a deliberative, digital, collaborative care model that houses various types of nondrug IBS treatment under one roof can provide meaningful benefit to patients,” Staller told GI & Hepatology News.

Importantly, he said, “patients chose which option they wanted. At the end of the day, the way that we should be thinking about IBS care is really making sure that we engage the patient with treatment choices,” Staller said.

This study had no specific funding. Three authors had relationships with Ayble Health. Lupe is a scientific advisor for Boomerang Health and paid lecturer for Takeda Pharmaceuticals. Staller disclosed having relationships with Mahana Therapeutics, Ardelyx Inc, Gemelli Biotech, Salix Pharmaceuticals, and Takeda Pharmaceuticals.

A version of this article appeared on Medscape.com.

SAN DIEGO — An artificial intelligence (AI)–enhanced digital collaborative care model led to rapid, clinically significant, and sustained symptom relief for patients with irritable bowel syndrome (IBS) seen at Cleveland Clinic, Cleveland, Ohio, an observational study found.

Symptom tracking at 4-week intervals showed that “almost everybody got better” regardless of IBS subtype, with relief starting in the first 4 weeks, Stephen Lupe, PsyD, gastrointestinal psychologist and director of Behavioral Medicine, Department of Gastroenterology, Hepatology, and Nutrition at Cleveland Clinic, Cleveland, said in an interview with GI & Hepatology News.

The findings were presented at Digestive Disease Week (DDW) 2025.

 

Digital Boost to Collaborative Care Model

The combination of dietary interventions and brain-gut behavioral therapy has demonstrated excellent outcomes for patients with IBS, but patients struggle to access these needed services, Lupe noted. A medical home collaborative care model in which patients get care from a multidisciplinary team has been shown to be a good way to successfully deliver this combination of care.

“When you do collaborative in-person care, people get better quicker,” Lupe said.

However, scaling access to this model remains a challenge. For their study, Cleveland Clinic researchers added an AI-enhanced digital platform, Ayble Health, to the in-person collaborative care model to expand access to disease-management services and evaluated whether it improved clinical outcomes for study’s 171 participants, who were recruited via social media advertisements.

Here’s how the platform works. Once a patient enrolls in Ayble Health, a personalized care plan is recommended based on a virtual visit, screening questionnaire, and baseline survey.

The platform includes brain-gut programs, including guided audio content on mindfulness, hypnosis, meditation, cognitive behavioral therapy, and breathing techniques; personalized nutrition support to find and remove trigger foods, a food barcode scanner, and a comprehensive groceries database; and AI-powered wellness tools to help manage and track symptoms. Lupe worked with Ayble Health to develop the platform’s behavioral health content and care pathways.

Patients may choose to follow any combination of three care pathways: A care team overseen by gastro-psychologists, dietitians, and gastroenterologists; a holistic nutrition program including a personalized elimination diet; and a brain-gut behavioral therapy program with gut-directed hypnosis, cognitive behavioral therapy, and acceptance and commitment therapy. They go at their own pace, can connect with Ayble Health’s virtual care team to help with education and goal setting, and continue to consult their Cleveland Clinic providers as needed for evaluation and treatment.

“The care team is still there. We’ve just augmented it to make sure that as many people as possible get behavioral skills training and dietary support, with monitoring between visits — instead of the traditional, ‘I’ll see you in 6 months approach,” Lupe explained.

 

IBS Symptom Scores Improve

Of the study’s 171 patients, 20 had IBS-diarrhea, 23 had IBS-constipation, 32 had IBS-mixed, and 8 had IBS-unspecified. The remaining 88 patients reported IBS without indication of subtype.

At intake, all patients had active IBS symptoms, with scores ≥ 75 on the IBS symptom severity scale (IBS-SSS). Most patients enrolled in more than one care pathway, and 95% of participants completed at least 4 weeks on their chosen pathways.

Overall, patients saw an average 140-point decrease in IBS-SSS from intake through follow-up lasting up to 42 weeks. A drop in IBS-SSS score ≥ 50 points was considered a clinically meaningful change.

Symptom improvements occurred as early as week 4, were sustained and were uniform across IBS subtypes, suggesting that the AI-enhanced digital collaborative care model has wide utility in patients with IBS, Lupe said.

Patients with the most severe IBS symptoms showed the greatest improvement, but even 50% of those with mild symptoms had clinically meaningful changes in IBS-SSS.

Improvement in IBS symptoms was seen across all care pathways, but the combination of multiple pathways improved outcomes better than a single care pathway alone. The combination of nutrition and brain-gut behavioral therapy demonstrated the greatest reduction in IBS-SSS scores and proportion of patients achieving clinically meaningful results (95%).

The digital comprehensive car model for IBS is now “up and running” at Cleveland Clinic, and the team plans to proactively reach out to patients with gastrointestinal disorders recently seen at their center to alert them to the availability of this tool, Lupe said.

A randomized controlled trial is planned to further validate these observational findings, he added.

 

‘Wave of the Future’

The digital collaborative care model is “innovative, and I think is the wave of the future,” Kyle Staller, MD, MPH, gastroenterologist and director of the Gastrointestinal Motility Laboratory at Massachusetts General Hospital, Boston, who wasn’t involved in the study, told GI & Hepatology News.

“These digital platforms bundle nondrug options, such as cognitive-behavioral therapy, dietary therapy, hypnotherapy, so patients can choose what suits them, rather than the gastroenterologist hunting down each individual resource, which requires a lot of work,” Staller said.

The study “provides real-world evidence that a deliberative, digital, collaborative care model that houses various types of nondrug IBS treatment under one roof can provide meaningful benefit to patients,” Staller told GI & Hepatology News.

Importantly, he said, “patients chose which option they wanted. At the end of the day, the way that we should be thinking about IBS care is really making sure that we engage the patient with treatment choices,” Staller said.

This study had no specific funding. Three authors had relationships with Ayble Health. Lupe is a scientific advisor for Boomerang Health and paid lecturer for Takeda Pharmaceuticals. Staller disclosed having relationships with Mahana Therapeutics, Ardelyx Inc, Gemelli Biotech, Salix Pharmaceuticals, and Takeda Pharmaceuticals.

A version of this article appeared on Medscape.com.

SAN DIEGO — An artificial intelligence (AI)–enhanced digital collaborative care model led to rapid, clinically significant, and sustained symptom relief for patients with irritable bowel syndrome (IBS) seen at Cleveland Clinic, Cleveland, Ohio, an observational study found.

Symptom tracking at 4-week intervals showed that “almost everybody got better” regardless of IBS subtype, with relief starting in the first 4 weeks, Stephen Lupe, PsyD, gastrointestinal psychologist and director of Behavioral Medicine, Department of Gastroenterology, Hepatology, and Nutrition at Cleveland Clinic, Cleveland, said in an interview with GI & Hepatology News.

The findings were presented at Digestive Disease Week (DDW) 2025.

 

Digital Boost to Collaborative Care Model

The combination of dietary interventions and brain-gut behavioral therapy has demonstrated excellent outcomes for patients with IBS, but patients struggle to access these needed services, Lupe noted. A medical home collaborative care model in which patients get care from a multidisciplinary team has been shown to be a good way to successfully deliver this combination of care.

“When you do collaborative in-person care, people get better quicker,” Lupe said.

However, scaling access to this model remains a challenge. For their study, Cleveland Clinic researchers added an AI-enhanced digital platform, Ayble Health, to the in-person collaborative care model to expand access to disease-management services and evaluated whether it improved clinical outcomes for study’s 171 participants, who were recruited via social media advertisements.

Here’s how the platform works. Once a patient enrolls in Ayble Health, a personalized care plan is recommended based on a virtual visit, screening questionnaire, and baseline survey.

The platform includes brain-gut programs, including guided audio content on mindfulness, hypnosis, meditation, cognitive behavioral therapy, and breathing techniques; personalized nutrition support to find and remove trigger foods, a food barcode scanner, and a comprehensive groceries database; and AI-powered wellness tools to help manage and track symptoms. Lupe worked with Ayble Health to develop the platform’s behavioral health content and care pathways.

Patients may choose to follow any combination of three care pathways: A care team overseen by gastro-psychologists, dietitians, and gastroenterologists; a holistic nutrition program including a personalized elimination diet; and a brain-gut behavioral therapy program with gut-directed hypnosis, cognitive behavioral therapy, and acceptance and commitment therapy. They go at their own pace, can connect with Ayble Health’s virtual care team to help with education and goal setting, and continue to consult their Cleveland Clinic providers as needed for evaluation and treatment.

“The care team is still there. We’ve just augmented it to make sure that as many people as possible get behavioral skills training and dietary support, with monitoring between visits — instead of the traditional, ‘I’ll see you in 6 months approach,” Lupe explained.

 

IBS Symptom Scores Improve

Of the study’s 171 patients, 20 had IBS-diarrhea, 23 had IBS-constipation, 32 had IBS-mixed, and 8 had IBS-unspecified. The remaining 88 patients reported IBS without indication of subtype.

At intake, all patients had active IBS symptoms, with scores ≥ 75 on the IBS symptom severity scale (IBS-SSS). Most patients enrolled in more than one care pathway, and 95% of participants completed at least 4 weeks on their chosen pathways.

Overall, patients saw an average 140-point decrease in IBS-SSS from intake through follow-up lasting up to 42 weeks. A drop in IBS-SSS score ≥ 50 points was considered a clinically meaningful change.

Symptom improvements occurred as early as week 4, were sustained and were uniform across IBS subtypes, suggesting that the AI-enhanced digital collaborative care model has wide utility in patients with IBS, Lupe said.

Patients with the most severe IBS symptoms showed the greatest improvement, but even 50% of those with mild symptoms had clinically meaningful changes in IBS-SSS.

Improvement in IBS symptoms was seen across all care pathways, but the combination of multiple pathways improved outcomes better than a single care pathway alone. The combination of nutrition and brain-gut behavioral therapy demonstrated the greatest reduction in IBS-SSS scores and proportion of patients achieving clinically meaningful results (95%).

The digital comprehensive car model for IBS is now “up and running” at Cleveland Clinic, and the team plans to proactively reach out to patients with gastrointestinal disorders recently seen at their center to alert them to the availability of this tool, Lupe said.

A randomized controlled trial is planned to further validate these observational findings, he added.

 

‘Wave of the Future’

The digital collaborative care model is “innovative, and I think is the wave of the future,” Kyle Staller, MD, MPH, gastroenterologist and director of the Gastrointestinal Motility Laboratory at Massachusetts General Hospital, Boston, who wasn’t involved in the study, told GI & Hepatology News.

“These digital platforms bundle nondrug options, such as cognitive-behavioral therapy, dietary therapy, hypnotherapy, so patients can choose what suits them, rather than the gastroenterologist hunting down each individual resource, which requires a lot of work,” Staller said.

The study “provides real-world evidence that a deliberative, digital, collaborative care model that houses various types of nondrug IBS treatment under one roof can provide meaningful benefit to patients,” Staller told GI & Hepatology News.

Importantly, he said, “patients chose which option they wanted. At the end of the day, the way that we should be thinking about IBS care is really making sure that we engage the patient with treatment choices,” Staller said.

This study had no specific funding. Three authors had relationships with Ayble Health. Lupe is a scientific advisor for Boomerang Health and paid lecturer for Takeda Pharmaceuticals. Staller disclosed having relationships with Mahana Therapeutics, Ardelyx Inc, Gemelli Biotech, Salix Pharmaceuticals, and Takeda Pharmaceuticals.

A version of this article appeared on Medscape.com.

SAN DIEGO — A 20-year initiative by Kaiser Permanente Northern California that assessed colorectal cancer (CRC) screening status and offered flexible options for screening has made a huge difference in CRC incidence, deaths, and racial disparities, an analysis showed.

“The program promptly doubled the proportion of people up to date with screening,” reported lead investigator Douglas A. Corley, MD, PhD, AGAF, a research scientist with Kaiser’s Division of Research, at a press briefing held on April 24, ahead of a presentation at the Digestive Disease Week® (DDW) 2025.

Additionally, within about 10 years, cancer rates were cut by a third, deaths were halved for the second most common cause of cancer deaths in the United States, and the differences that had previously been seen by race or ethnicity were largely eliminated, he said.

“Ten years ago, there were big gaps in cancer risk and death, especially among our Black patients. Now, those differences are nearly gone,” Corley said.

 

Closing the Gap

A systematic CRC screening program was implemented across Kaiser Permanente Northern California. The program included proactive outreach to members who were overdue for screening and mailing them fecal immunochemical test (FIT) kits for at-home use.

Corley and colleagues tracked screening status and CRC incidence and mortality annually from 2000 to 2019 among about 1.1 million members aged 50-75 years across 22 medical centers of the integrated healthcare system. The cohort included American Indian or Alaska Native, Asian, Black, Hispanic, Native Hawaiian or Pacific Islander, and White members.

Screening rates via FIT, colonoscopy, or sigmoidoscopy more than doubled after starting the program, from about 37% in the early years to about 80% within a few years, and it stayed that high through 2019, Corley reported. 

“Importantly, these large increases occurred across the whole population with only small differences,” he said. 

For example, about 76% of Hispanic members, 77% of Black members, 82% of White members, and 83% of Asian members were up to date in the later years and through 2019.

“This shows that systematic, comparable outreach can provide a level playing field for completion of preventive care,” Corley said.

After an expected early uptick in CRC incidence due to early detection, incidence later declined and by 2019 had dropped approximately 30% across the groups.

 

Long-Standing Disparities Erased

CRC deaths also fell by about 50% across all groups, with the largest decline among Black members, Corley noted.

Racial and ethnic disparities in both CRC incidence and mortality have long existed, with Black patients in particular experiencing higher risks and worse outcomes, likely from a mixture of risk factors and healthcare utilization, Corley said.

Offering outreach and equal access to screening in the Kaiser program erased those long-standing disparities.

“It’s remarkable that some of these large differences in mortality by race and ethnicity that we saw two decades ago, and which are found throughout the United States, are now similar to small chance variation in the population,” Corley said.

Flexibility was key to getting more people screened, he noted. “It’s about reaching people at their homes and offering a choice to patients. It’s an astonishingly simple concept.”

It’s important to note that these findings stem from a large, integrated healthcare system, which may differ from other settings, although similar outreach strategies have succeeded in safety net clinics and smaller practices, Corley added.

By boosting screening rates to 80%, the health system reached the level that’s essentially been defined in the past as our goal of screening programs, said Loren Laine, MD, AGAF, professor of medicine (digestive diseases) at Yale School of Medicine, New Haven, Connecticut, and chair of this year’s DDW. 

“It shows that if health systems institute programmatic screening for all their covered individuals, they could markedly increase screening, said Laine, who also served as moderator of the press briefing.

“Most importantly, of course, [screening] was associated with a reduction in colorectal cancer incidence and deaths,” he said.

The study had no commercial funding. Corley reported having no relevant conflicts of interest.

Laine’s disclosures included consulting and/or relationships with Medtronic, Phathom Pharmaceuticals, Biohaven, Celgene, Intercept, Merck, and Pfizer.

A version of this article appeared on Medscape.com.

SAN DIEGO — A 20-year initiative by Kaiser Permanente Northern California that assessed colorectal cancer (CRC) screening status and offered flexible options for screening has made a huge difference in CRC incidence, deaths, and racial disparities, an analysis showed.

“The program promptly doubled the proportion of people up to date with screening,” reported lead investigator Douglas A. Corley, MD, PhD, AGAF, a research scientist with Kaiser’s Division of Research, at a press briefing held on April 24, ahead of a presentation at the Digestive Disease Week® (DDW) 2025.

Additionally, within about 10 years, cancer rates were cut by a third, deaths were halved for the second most common cause of cancer deaths in the United States, and the differences that had previously been seen by race or ethnicity were largely eliminated, he said.

“Ten years ago, there were big gaps in cancer risk and death, especially among our Black patients. Now, those differences are nearly gone,” Corley said.

 

Closing the Gap

A systematic CRC screening program was implemented across Kaiser Permanente Northern California. The program included proactive outreach to members who were overdue for screening and mailing them fecal immunochemical test (FIT) kits for at-home use.

Corley and colleagues tracked screening status and CRC incidence and mortality annually from 2000 to 2019 among about 1.1 million members aged 50-75 years across 22 medical centers of the integrated healthcare system. The cohort included American Indian or Alaska Native, Asian, Black, Hispanic, Native Hawaiian or Pacific Islander, and White members.

Screening rates via FIT, colonoscopy, or sigmoidoscopy more than doubled after starting the program, from about 37% in the early years to about 80% within a few years, and it stayed that high through 2019, Corley reported. 

“Importantly, these large increases occurred across the whole population with only small differences,” he said. 

For example, about 76% of Hispanic members, 77% of Black members, 82% of White members, and 83% of Asian members were up to date in the later years and through 2019.

“This shows that systematic, comparable outreach can provide a level playing field for completion of preventive care,” Corley said.

After an expected early uptick in CRC incidence due to early detection, incidence later declined and by 2019 had dropped approximately 30% across the groups.

 

Long-Standing Disparities Erased

CRC deaths also fell by about 50% across all groups, with the largest decline among Black members, Corley noted.

Racial and ethnic disparities in both CRC incidence and mortality have long existed, with Black patients in particular experiencing higher risks and worse outcomes, likely from a mixture of risk factors and healthcare utilization, Corley said.

Offering outreach and equal access to screening in the Kaiser program erased those long-standing disparities.

“It’s remarkable that some of these large differences in mortality by race and ethnicity that we saw two decades ago, and which are found throughout the United States, are now similar to small chance variation in the population,” Corley said.

Flexibility was key to getting more people screened, he noted. “It’s about reaching people at their homes and offering a choice to patients. It’s an astonishingly simple concept.”

It’s important to note that these findings stem from a large, integrated healthcare system, which may differ from other settings, although similar outreach strategies have succeeded in safety net clinics and smaller practices, Corley added.

By boosting screening rates to 80%, the health system reached the level that’s essentially been defined in the past as our goal of screening programs, said Loren Laine, MD, AGAF, professor of medicine (digestive diseases) at Yale School of Medicine, New Haven, Connecticut, and chair of this year’s DDW. 

“It shows that if health systems institute programmatic screening for all their covered individuals, they could markedly increase screening, said Laine, who also served as moderator of the press briefing.

“Most importantly, of course, [screening] was associated with a reduction in colorectal cancer incidence and deaths,” he said.

The study had no commercial funding. Corley reported having no relevant conflicts of interest.

Laine’s disclosures included consulting and/or relationships with Medtronic, Phathom Pharmaceuticals, Biohaven, Celgene, Intercept, Merck, and Pfizer.

A version of this article appeared on Medscape.com.

SAN DIEGO — A 20-year initiative by Kaiser Permanente Northern California that assessed colorectal cancer (CRC) screening status and offered flexible options for screening has made a huge difference in CRC incidence, deaths, and racial disparities, an analysis showed.

“The program promptly doubled the proportion of people up to date with screening,” reported lead investigator Douglas A. Corley, MD, PhD, AGAF, a research scientist with Kaiser’s Division of Research, at a press briefing held on April 24, ahead of a presentation at the Digestive Disease Week® (DDW) 2025.

Additionally, within about 10 years, cancer rates were cut by a third, deaths were halved for the second most common cause of cancer deaths in the United States, and the differences that had previously been seen by race or ethnicity were largely eliminated, he said.

“Ten years ago, there were big gaps in cancer risk and death, especially among our Black patients. Now, those differences are nearly gone,” Corley said.

 

Closing the Gap

A systematic CRC screening program was implemented across Kaiser Permanente Northern California. The program included proactive outreach to members who were overdue for screening and mailing them fecal immunochemical test (FIT) kits for at-home use.

Corley and colleagues tracked screening status and CRC incidence and mortality annually from 2000 to 2019 among about 1.1 million members aged 50-75 years across 22 medical centers of the integrated healthcare system. The cohort included American Indian or Alaska Native, Asian, Black, Hispanic, Native Hawaiian or Pacific Islander, and White members.

Screening rates via FIT, colonoscopy, or sigmoidoscopy more than doubled after starting the program, from about 37% in the early years to about 80% within a few years, and it stayed that high through 2019, Corley reported. 

“Importantly, these large increases occurred across the whole population with only small differences,” he said. 

For example, about 76% of Hispanic members, 77% of Black members, 82% of White members, and 83% of Asian members were up to date in the later years and through 2019.

“This shows that systematic, comparable outreach can provide a level playing field for completion of preventive care,” Corley said.

After an expected early uptick in CRC incidence due to early detection, incidence later declined and by 2019 had dropped approximately 30% across the groups.

 

Long-Standing Disparities Erased

CRC deaths also fell by about 50% across all groups, with the largest decline among Black members, Corley noted.

Racial and ethnic disparities in both CRC incidence and mortality have long existed, with Black patients in particular experiencing higher risks and worse outcomes, likely from a mixture of risk factors and healthcare utilization, Corley said.

Offering outreach and equal access to screening in the Kaiser program erased those long-standing disparities.

“It’s remarkable that some of these large differences in mortality by race and ethnicity that we saw two decades ago, and which are found throughout the United States, are now similar to small chance variation in the population,” Corley said.

Flexibility was key to getting more people screened, he noted. “It’s about reaching people at their homes and offering a choice to patients. It’s an astonishingly simple concept.”

It’s important to note that these findings stem from a large, integrated healthcare system, which may differ from other settings, although similar outreach strategies have succeeded in safety net clinics and smaller practices, Corley added.

By boosting screening rates to 80%, the health system reached the level that’s essentially been defined in the past as our goal of screening programs, said Loren Laine, MD, AGAF, professor of medicine (digestive diseases) at Yale School of Medicine, New Haven, Connecticut, and chair of this year’s DDW. 

“It shows that if health systems institute programmatic screening for all their covered individuals, they could markedly increase screening, said Laine, who also served as moderator of the press briefing.

“Most importantly, of course, [screening] was associated with a reduction in colorectal cancer incidence and deaths,” he said.

The study had no commercial funding. Corley reported having no relevant conflicts of interest.

Laine’s disclosures included consulting and/or relationships with Medtronic, Phathom Pharmaceuticals, Biohaven, Celgene, Intercept, Merck, and Pfizer.

A version of this article appeared on Medscape.com.