IBD & Intestinal Disorders

CHARLOTTE, N.C. – People with moderate to severe ulcerative colitis benefit from stronger treatment from the start – a combination of monoclonal antibodies – compared with induction with either agent alone, a phase 2a study demonstrates.

Researchers compared the combination therapy of guselkumab and golimumab (both from Janssen) for 12 weeks, followed by guselkumab monotherapy up to week 38, versus either agent as monotherapy for the full 38 weeks.

Guselkumab is an interleukin-23p19 subunit antagonist being studied to treat inflammatory bowel disease (IBD). Golimumab is a TNF-alpha antagonist being evaluated for ulcerative colitis.

University of Western Ontario, London

The combination induction strategy “achieved higher rates of clinical remission, endoscopic improvement, composite endpoint of histologic remission, and endoscopic improvement,” said Brian G. Feagan, MD, senior scientific director at the contract research organization Alimentiv and a gastroenterologist at Western University in London, Ont.

The findings were presented at the annual meeting of the American College of Gastroenterology.
 

Study design

The current research builds on previous week 12 VEGA study results. The earlier findings indicated that blocking interleukin-23p19 by guselkumab and TNF-alpha with golimumab was superior on multiple measures, compared with monotherapy.

The new findings are from a randomized, double-blind, proof-of-concept study that included 214 adults with moderately to severely active ulcerative colitis. Participants were naive to TNF-alpha antagonists and refractory or intolerant to conventional therapy.

Of the participants, 71 were randomly assigned to receive guselkumab, 200 mg intravenous (IV) at baseline and at weeks 4 and 8, plus 100 mg subcutaneous (SC) every 8 weeks.

Another 72 participants received golimumab, 200 mg SC at baseline, and 100 mg SC at weeks 2, 6, and 10, and every 4 weeks thereafter.

The combination group of 71 participants received guselkumab 200 mg IV and golimumab 200 mg SC at baseline, followed by golimumab 100 mg SC at weeks 2, 6, and 10, and guselkumab 200 mg IV at weeks 4 and 8. At week 12, this group switched to monotherapy with guselkumab, 100 mg SC every 8 weeks.

Overall, 13% of patients discontinued treatment prior to week 34, the time of final dose of study intervention.

Dr. Feagan noted that they did not see differences between any adverse event, serious adverse event, or adverse event leading to discontinuation among the treatment groups.
 

Key findings through week 38

The rate of clinical remission in the combination group was 44%. The rate was lower with guselkumab monotherapy at 31% and golimumab monotherapy at 22% at week 38. These percentages were based on a full Mayo Score of 2 or less and no individual subscore greater than 1.

At the same time, the rates of clinical remission by modified Mayo score also favored the combination group at 48%, followed by 31% in the guselkumab group and 21% in the golimumab cohort.

Endoscopic improvement, endoscopic normalization, histologic remission, and composite histologic-endoscopic endpoints were also greater in the combination group than in the monotherapy groups.

“Quite striking differences were maintained up to week 38,” Dr. Feagan said. “This combination treatment warrants further investigation, and phase 3 trials are underway.”

He added that, while they were concerned about serious infection, they did not see any differences, with only two serious infections in each of the three groups.

Opportunistic infections were reported for two patients in the combination group: extrapulmonary tuberculosis and cytomegalovirus colitis. No opportunistic infections occurred in the monotherapy groups.
 

Valuable data

“The early study results, such as the VEGA study, appear promising for combination biologics with a good safety profile,” Jean-Paul Achkar, MD, staff physician in the Center for Inflammatory Bowel Disease at Cleveland Clinic and the Kenneth Rainin Endowed Chair for IBD Research, said when asked to comment.

“These data are particularly valuable as we have seemingly reached a therapeutic response ceiling for single-biologic therapy, and we need to determine the added benefit and safety profile of a combination of two biologics or the combination of a biologic and a small molecule,” added Dr. Achkar, who served as the session comoderator.

A meeting attendee asked about the likelihood of regulatory approval for this combination based on evidence like this study.

“I think they have to,” Dr. Feagan said. “We’ve probably seen our best results yet in Crohn’s disease, and we’re still at 50% [response rate for monotherapy]. If we’re ever going to come to terms with IBD, I don’t think it’s monotherapy.”

Dr. Feagan added that with combination therapy, “physicians will often worry about economics, but I think that’s a surrogate for their concerns about infection.”

However, he noted that “the better the agents we have, the better the incremental cost effectiveness. So, I don’t think economics is the issue; the issue is safety.”

Another meeting attendee asked if the results might apply to other biologic combinations.

“This model was picked to show the additive effect of the anti-p19 and the TNF antagonist,” Dr. Feagan said.

Similar results could be expected with a combination of treatments from the same classes, he said, but the treatment potential of other drug-class combination is unclear.

The study was funded by Janssen Research and Development. Dr. Feagan reports being a consultant for Janssen. Dr. Achkar reports no relevant financial relationships.

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

CHARLOTTE, N.C. – People with moderate to severe ulcerative colitis benefit from stronger treatment from the start – a combination of monoclonal antibodies – compared with induction with either agent alone, a phase 2a study demonstrates.

Researchers compared the combination therapy of guselkumab and golimumab (both from Janssen) for 12 weeks, followed by guselkumab monotherapy up to week 38, versus either agent as monotherapy for the full 38 weeks.

Guselkumab is an interleukin-23p19 subunit antagonist being studied to treat inflammatory bowel disease (IBD). Golimumab is a TNF-alpha antagonist being evaluated for ulcerative colitis.

University of Western Ontario, London

The combination induction strategy “achieved higher rates of clinical remission, endoscopic improvement, composite endpoint of histologic remission, and endoscopic improvement,” said Brian G. Feagan, MD, senior scientific director at the contract research organization Alimentiv and a gastroenterologist at Western University in London, Ont.

The findings were presented at the annual meeting of the American College of Gastroenterology.
 

Study design

The current research builds on previous week 12 VEGA study results. The earlier findings indicated that blocking interleukin-23p19 by guselkumab and TNF-alpha with golimumab was superior on multiple measures, compared with monotherapy.

The new findings are from a randomized, double-blind, proof-of-concept study that included 214 adults with moderately to severely active ulcerative colitis. Participants were naive to TNF-alpha antagonists and refractory or intolerant to conventional therapy.

Of the participants, 71 were randomly assigned to receive guselkumab, 200 mg intravenous (IV) at baseline and at weeks 4 and 8, plus 100 mg subcutaneous (SC) every 8 weeks.

Another 72 participants received golimumab, 200 mg SC at baseline, and 100 mg SC at weeks 2, 6, and 10, and every 4 weeks thereafter.

The combination group of 71 participants received guselkumab 200 mg IV and golimumab 200 mg SC at baseline, followed by golimumab 100 mg SC at weeks 2, 6, and 10, and guselkumab 200 mg IV at weeks 4 and 8. At week 12, this group switched to monotherapy with guselkumab, 100 mg SC every 8 weeks.

Overall, 13% of patients discontinued treatment prior to week 34, the time of final dose of study intervention.

Dr. Feagan noted that they did not see differences between any adverse event, serious adverse event, or adverse event leading to discontinuation among the treatment groups.
 

Key findings through week 38

The rate of clinical remission in the combination group was 44%. The rate was lower with guselkumab monotherapy at 31% and golimumab monotherapy at 22% at week 38. These percentages were based on a full Mayo Score of 2 or less and no individual subscore greater than 1.

At the same time, the rates of clinical remission by modified Mayo score also favored the combination group at 48%, followed by 31% in the guselkumab group and 21% in the golimumab cohort.

Endoscopic improvement, endoscopic normalization, histologic remission, and composite histologic-endoscopic endpoints were also greater in the combination group than in the monotherapy groups.

“Quite striking differences were maintained up to week 38,” Dr. Feagan said. “This combination treatment warrants further investigation, and phase 3 trials are underway.”

He added that, while they were concerned about serious infection, they did not see any differences, with only two serious infections in each of the three groups.

Opportunistic infections were reported for two patients in the combination group: extrapulmonary tuberculosis and cytomegalovirus colitis. No opportunistic infections occurred in the monotherapy groups.
 

Valuable data

“The early study results, such as the VEGA study, appear promising for combination biologics with a good safety profile,” Jean-Paul Achkar, MD, staff physician in the Center for Inflammatory Bowel Disease at Cleveland Clinic and the Kenneth Rainin Endowed Chair for IBD Research, said when asked to comment.

“These data are particularly valuable as we have seemingly reached a therapeutic response ceiling for single-biologic therapy, and we need to determine the added benefit and safety profile of a combination of two biologics or the combination of a biologic and a small molecule,” added Dr. Achkar, who served as the session comoderator.

A meeting attendee asked about the likelihood of regulatory approval for this combination based on evidence like this study.

“I think they have to,” Dr. Feagan said. “We’ve probably seen our best results yet in Crohn’s disease, and we’re still at 50% [response rate for monotherapy]. If we’re ever going to come to terms with IBD, I don’t think it’s monotherapy.”

Dr. Feagan added that with combination therapy, “physicians will often worry about economics, but I think that’s a surrogate for their concerns about infection.”

However, he noted that “the better the agents we have, the better the incremental cost effectiveness. So, I don’t think economics is the issue; the issue is safety.”

Another meeting attendee asked if the results might apply to other biologic combinations.

“This model was picked to show the additive effect of the anti-p19 and the TNF antagonist,” Dr. Feagan said.

Similar results could be expected with a combination of treatments from the same classes, he said, but the treatment potential of other drug-class combination is unclear.

The study was funded by Janssen Research and Development. Dr. Feagan reports being a consultant for Janssen. Dr. Achkar reports no relevant financial relationships.

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

CHARLOTTE, N.C. – People with moderate to severe ulcerative colitis benefit from stronger treatment from the start – a combination of monoclonal antibodies – compared with induction with either agent alone, a phase 2a study demonstrates.

Researchers compared the combination therapy of guselkumab and golimumab (both from Janssen) for 12 weeks, followed by guselkumab monotherapy up to week 38, versus either agent as monotherapy for the full 38 weeks.

Guselkumab is an interleukin-23p19 subunit antagonist being studied to treat inflammatory bowel disease (IBD). Golimumab is a TNF-alpha antagonist being evaluated for ulcerative colitis.

University of Western Ontario, London

The combination induction strategy “achieved higher rates of clinical remission, endoscopic improvement, composite endpoint of histologic remission, and endoscopic improvement,” said Brian G. Feagan, MD, senior scientific director at the contract research organization Alimentiv and a gastroenterologist at Western University in London, Ont.

The findings were presented at the annual meeting of the American College of Gastroenterology.
 

Study design

The current research builds on previous week 12 VEGA study results. The earlier findings indicated that blocking interleukin-23p19 by guselkumab and TNF-alpha with golimumab was superior on multiple measures, compared with monotherapy.

The new findings are from a randomized, double-blind, proof-of-concept study that included 214 adults with moderately to severely active ulcerative colitis. Participants were naive to TNF-alpha antagonists and refractory or intolerant to conventional therapy.

Of the participants, 71 were randomly assigned to receive guselkumab, 200 mg intravenous (IV) at baseline and at weeks 4 and 8, plus 100 mg subcutaneous (SC) every 8 weeks.

Another 72 participants received golimumab, 200 mg SC at baseline, and 100 mg SC at weeks 2, 6, and 10, and every 4 weeks thereafter.

The combination group of 71 participants received guselkumab 200 mg IV and golimumab 200 mg SC at baseline, followed by golimumab 100 mg SC at weeks 2, 6, and 10, and guselkumab 200 mg IV at weeks 4 and 8. At week 12, this group switched to monotherapy with guselkumab, 100 mg SC every 8 weeks.

Overall, 13% of patients discontinued treatment prior to week 34, the time of final dose of study intervention.

Dr. Feagan noted that they did not see differences between any adverse event, serious adverse event, or adverse event leading to discontinuation among the treatment groups.
 

Key findings through week 38

The rate of clinical remission in the combination group was 44%. The rate was lower with guselkumab monotherapy at 31% and golimumab monotherapy at 22% at week 38. These percentages were based on a full Mayo Score of 2 or less and no individual subscore greater than 1.

At the same time, the rates of clinical remission by modified Mayo score also favored the combination group at 48%, followed by 31% in the guselkumab group and 21% in the golimumab cohort.

Endoscopic improvement, endoscopic normalization, histologic remission, and composite histologic-endoscopic endpoints were also greater in the combination group than in the monotherapy groups.

“Quite striking differences were maintained up to week 38,” Dr. Feagan said. “This combination treatment warrants further investigation, and phase 3 trials are underway.”

He added that, while they were concerned about serious infection, they did not see any differences, with only two serious infections in each of the three groups.

Opportunistic infections were reported for two patients in the combination group: extrapulmonary tuberculosis and cytomegalovirus colitis. No opportunistic infections occurred in the monotherapy groups.
 

Valuable data

“The early study results, such as the VEGA study, appear promising for combination biologics with a good safety profile,” Jean-Paul Achkar, MD, staff physician in the Center for Inflammatory Bowel Disease at Cleveland Clinic and the Kenneth Rainin Endowed Chair for IBD Research, said when asked to comment.

“These data are particularly valuable as we have seemingly reached a therapeutic response ceiling for single-biologic therapy, and we need to determine the added benefit and safety profile of a combination of two biologics or the combination of a biologic and a small molecule,” added Dr. Achkar, who served as the session comoderator.

A meeting attendee asked about the likelihood of regulatory approval for this combination based on evidence like this study.

“I think they have to,” Dr. Feagan said. “We’ve probably seen our best results yet in Crohn’s disease, and we’re still at 50% [response rate for monotherapy]. If we’re ever going to come to terms with IBD, I don’t think it’s monotherapy.”

Dr. Feagan added that with combination therapy, “physicians will often worry about economics, but I think that’s a surrogate for their concerns about infection.”

However, he noted that “the better the agents we have, the better the incremental cost effectiveness. So, I don’t think economics is the issue; the issue is safety.”

Another meeting attendee asked if the results might apply to other biologic combinations.

“This model was picked to show the additive effect of the anti-p19 and the TNF antagonist,” Dr. Feagan said.

Similar results could be expected with a combination of treatments from the same classes, he said, but the treatment potential of other drug-class combination is unclear.

The study was funded by Janssen Research and Development. Dr. Feagan reports being a consultant for Janssen. Dr. Achkar reports no relevant financial relationships.

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

Key clinical point: Gut microbial composition differed among patients with diarrhea-predominant irritable bowel syndrome (IBS-D) who were positive vs negative for breath test (IBS-BT+ vs IBS-BT−), with patients who were IBS-BT+ responding better to rifaximin therapy.

Major finding: Beta-diversity differed significantly among patients with IBS-BT+, those with IBS-BT−, and non-IBS healthy controls (P = .005). The IBS Symptom Severity Scores (SSS), Gastrointestinal Symptom Rating Scale scores, and Bristol Stool Form Scale scores decreased significantly after rifaximin treatment in the IBS-BT+ group (all P < .05); however, only IBS-SSS scores decreased significantly in the IBS-BT− group (P = .001).

Study details: The data come from a clinical trial including 176 participants, of which 49 were BT− healthy controls and 127 were patients with IBS-D who were evaluated before and after rifaximin therapy.

Disclosures: This study was supported by the National Natural Science Foundation of China and the Michigan Medicine-PKUHSC Joint Institute for Translational and Clinical Research. The authors declared no conflicts of interest.

Source: Liu Z et al. Patients with breath test positive are necessary to be identified from irritable bowel syndrome: A clinical trial based on microbiomics and rifaximin sensitivity. Chin Med J (Engl). 2022;135(14):1716-1727 (Aug 25). Doi: 10.1097/CM9.0000000000002294

Key clinical point: Gut microbial composition differed among patients with diarrhea-predominant irritable bowel syndrome (IBS-D) who were positive vs negative for breath test (IBS-BT+ vs IBS-BT−), with patients who were IBS-BT+ responding better to rifaximin therapy.

Major finding: Beta-diversity differed significantly among patients with IBS-BT+, those with IBS-BT−, and non-IBS healthy controls (P = .005). The IBS Symptom Severity Scores (SSS), Gastrointestinal Symptom Rating Scale scores, and Bristol Stool Form Scale scores decreased significantly after rifaximin treatment in the IBS-BT+ group (all P < .05); however, only IBS-SSS scores decreased significantly in the IBS-BT− group (P = .001).

Study details: The data come from a clinical trial including 176 participants, of which 49 were BT− healthy controls and 127 were patients with IBS-D who were evaluated before and after rifaximin therapy.

Disclosures: This study was supported by the National Natural Science Foundation of China and the Michigan Medicine-PKUHSC Joint Institute for Translational and Clinical Research. The authors declared no conflicts of interest.

Source: Liu Z et al. Patients with breath test positive are necessary to be identified from irritable bowel syndrome: A clinical trial based on microbiomics and rifaximin sensitivity. Chin Med J (Engl). 2022;135(14):1716-1727 (Aug 25). Doi: 10.1097/CM9.0000000000002294

Key clinical point: Gut microbial composition differed among patients with diarrhea-predominant irritable bowel syndrome (IBS-D) who were positive vs negative for breath test (IBS-BT+ vs IBS-BT−), with patients who were IBS-BT+ responding better to rifaximin therapy.

Major finding: Beta-diversity differed significantly among patients with IBS-BT+, those with IBS-BT−, and non-IBS healthy controls (P = .005). The IBS Symptom Severity Scores (SSS), Gastrointestinal Symptom Rating Scale scores, and Bristol Stool Form Scale scores decreased significantly after rifaximin treatment in the IBS-BT+ group (all P < .05); however, only IBS-SSS scores decreased significantly in the IBS-BT− group (P = .001).

Study details: The data come from a clinical trial including 176 participants, of which 49 were BT− healthy controls and 127 were patients with IBS-D who were evaluated before and after rifaximin therapy.

Disclosures: This study was supported by the National Natural Science Foundation of China and the Michigan Medicine-PKUHSC Joint Institute for Translational and Clinical Research. The authors declared no conflicts of interest.

Source: Liu Z et al. Patients with breath test positive are necessary to be identified from irritable bowel syndrome: A clinical trial based on microbiomics and rifaximin sensitivity. Chin Med J (Engl). 2022;135(14):1716-1727 (Aug 25). Doi: 10.1097/CM9.0000000000002294

Key clinical point: Sex and gender are critical for a better understanding of the differences in individual experiences of irritable bowel syndrome (IBS) and should be included in discussions of the disease’s etiology, presentations, and treatment strategies.

Major finding: Men with IBS had fewer psychiatric conditions (P = .027), fewer sleeping problems (P = .011), less chronic pain (P = .043), and fewer contacts with the healthcare system (P < .001) compared with women with IBS, with urgency to defecate being less frequent (P = .017) and stool frequency being higher (P = .034) in men with IBS.

Study details: The data come from a cross-sectional study including 293 patients (64 men) with IBS and 363 non-IBS controls (62 men).

Disclosures: This study was funded by FORSS-the Research Council of Southeast, Sweden. The authors declared no conflicts of interest.

Source: Bureychak T et al. Symptoms and health experience in irritable bowel syndrome with focus on men. Neurogastroenterol Motil. 2022;34(11):e14430 (Sep 8). Doi: 10.1111/nmo.14430

Key clinical point: Sex and gender are critical for a better understanding of the differences in individual experiences of irritable bowel syndrome (IBS) and should be included in discussions of the disease’s etiology, presentations, and treatment strategies.

Major finding: Men with IBS had fewer psychiatric conditions (P = .027), fewer sleeping problems (P = .011), less chronic pain (P = .043), and fewer contacts with the healthcare system (P < .001) compared with women with IBS, with urgency to defecate being less frequent (P = .017) and stool frequency being higher (P = .034) in men with IBS.

Study details: The data come from a cross-sectional study including 293 patients (64 men) with IBS and 363 non-IBS controls (62 men).

Disclosures: This study was funded by FORSS-the Research Council of Southeast, Sweden. The authors declared no conflicts of interest.

Source: Bureychak T et al. Symptoms and health experience in irritable bowel syndrome with focus on men. Neurogastroenterol Motil. 2022;34(11):e14430 (Sep 8). Doi: 10.1111/nmo.14430

Key clinical point: Sex and gender are critical for a better understanding of the differences in individual experiences of irritable bowel syndrome (IBS) and should be included in discussions of the disease’s etiology, presentations, and treatment strategies.

Major finding: Men with IBS had fewer psychiatric conditions (P = .027), fewer sleeping problems (P = .011), less chronic pain (P = .043), and fewer contacts with the healthcare system (P < .001) compared with women with IBS, with urgency to defecate being less frequent (P = .017) and stool frequency being higher (P = .034) in men with IBS.

Study details: The data come from a cross-sectional study including 293 patients (64 men) with IBS and 363 non-IBS controls (62 men).

Disclosures: This study was funded by FORSS-the Research Council of Southeast, Sweden. The authors declared no conflicts of interest.

Source: Bureychak T et al. Symptoms and health experience in irritable bowel syndrome with focus on men. Neurogastroenterol Motil. 2022;34(11):e14430 (Sep 8). Doi: 10.1111/nmo.14430

Key clinical point: Breath gas patterns are linked to distinct gut microtypes in diarrhea-predominant irritable bowel syndrome (IBS-D) and constipation-predominant IBS (IBS-C).

Major finding: Patients with IBS-D vs IBS-C had a higher area under the curve (AUC) for hydrogen (P = .02) and hydrogen sulfide (P = .002), whereas those with IBS-C vs IBS-D had a higher AUC for methane (P = .002). Higher breath methane in IBS-C correlated with higher breath microbial diversity, whereas higher breath hydrogen and hydrogen sulfide in IBS-D correlated with lower microbial diversity and higher relative abundance of hydrogen sulfide-producing bacteria, respectively.

Study details: The data come from two randomized controlled trials including patients with IBS-C (n = 124) and IBS-D (n = 47).

Disclosures: This study was partly funded by the Monica Lester Charitable Trust; Elias, Genevieve, and Georgianna Atol Charitable Trust; and others. Some authors declared receiving research grants or serving as consultants or speakers for various sources.

Source: Villanueva-Millan MJ et al. Methanogens and hydrogen sulfide producing bacteria guide distinct gut microbe profiles and irritable bowel syndrome subtypes. Am J Gastroenterol. 2022 (Sep 6). Doi: 10.14309/ajg.0000000000001997

Key clinical point: Breath gas patterns are linked to distinct gut microtypes in diarrhea-predominant irritable bowel syndrome (IBS-D) and constipation-predominant IBS (IBS-C).

Major finding: Patients with IBS-D vs IBS-C had a higher area under the curve (AUC) for hydrogen (P = .02) and hydrogen sulfide (P = .002), whereas those with IBS-C vs IBS-D had a higher AUC for methane (P = .002). Higher breath methane in IBS-C correlated with higher breath microbial diversity, whereas higher breath hydrogen and hydrogen sulfide in IBS-D correlated with lower microbial diversity and higher relative abundance of hydrogen sulfide-producing bacteria, respectively.

Study details: The data come from two randomized controlled trials including patients with IBS-C (n = 124) and IBS-D (n = 47).

Disclosures: This study was partly funded by the Monica Lester Charitable Trust; Elias, Genevieve, and Georgianna Atol Charitable Trust; and others. Some authors declared receiving research grants or serving as consultants or speakers for various sources.

Source: Villanueva-Millan MJ et al. Methanogens and hydrogen sulfide producing bacteria guide distinct gut microbe profiles and irritable bowel syndrome subtypes. Am J Gastroenterol. 2022 (Sep 6). Doi: 10.14309/ajg.0000000000001997

Key clinical point: Breath gas patterns are linked to distinct gut microtypes in diarrhea-predominant irritable bowel syndrome (IBS-D) and constipation-predominant IBS (IBS-C).

Major finding: Patients with IBS-D vs IBS-C had a higher area under the curve (AUC) for hydrogen (P = .02) and hydrogen sulfide (P = .002), whereas those with IBS-C vs IBS-D had a higher AUC for methane (P = .002). Higher breath methane in IBS-C correlated with higher breath microbial diversity, whereas higher breath hydrogen and hydrogen sulfide in IBS-D correlated with lower microbial diversity and higher relative abundance of hydrogen sulfide-producing bacteria, respectively.

Study details: The data come from two randomized controlled trials including patients with IBS-C (n = 124) and IBS-D (n = 47).

Disclosures: This study was partly funded by the Monica Lester Charitable Trust; Elias, Genevieve, and Georgianna Atol Charitable Trust; and others. Some authors declared receiving research grants or serving as consultants or speakers for various sources.

Source: Villanueva-Millan MJ et al. Methanogens and hydrogen sulfide producing bacteria guide distinct gut microbe profiles and irritable bowel syndrome subtypes. Am J Gastroenterol. 2022 (Sep 6). Doi: 10.14309/ajg.0000000000001997

Key clinical point: Fecal microbiota transfer (FMT) did not appear to be an effective treatment for irritable bowel syndrome (IBS) symptoms whether administered orally or via colonoscopy, gastroscopy, or a nasojejunal tube, with initial improvements wearing off drastically over time.

Major finding: Despite a significant improvement in the quality-of-life score in the FMT vs control group (mean difference 9.32; P = .0005), the overall change in IBS symptom severity score (P = .67) and the number of respondents considering all routes of administration (P = .19) were not significantly different between treatment arms.

Study details: Findings are from a meta-analysis of eight randomized controlled trials including 472 patients with IBS who received either FMT or autologous transfer/placebo (control group).

Disclosures: This study did not declare any source of funding. The authors declared no conflicts of interest.

Source: Abdelghafar YA et al. Efficacy and safety of fecal microbiota transplant in irritable bowel syndrome: An update based on meta‐analysis of randomized control trials. Health Sci Rep. 2022;5(5):e814 (Sep 12). Doi: 10.1002/hsr2.814

Key clinical point: Fecal microbiota transfer (FMT) did not appear to be an effective treatment for irritable bowel syndrome (IBS) symptoms whether administered orally or via colonoscopy, gastroscopy, or a nasojejunal tube, with initial improvements wearing off drastically over time.

Major finding: Despite a significant improvement in the quality-of-life score in the FMT vs control group (mean difference 9.32; P = .0005), the overall change in IBS symptom severity score (P = .67) and the number of respondents considering all routes of administration (P = .19) were not significantly different between treatment arms.

Study details: Findings are from a meta-analysis of eight randomized controlled trials including 472 patients with IBS who received either FMT or autologous transfer/placebo (control group).

Disclosures: This study did not declare any source of funding. The authors declared no conflicts of interest.

Source: Abdelghafar YA et al. Efficacy and safety of fecal microbiota transplant in irritable bowel syndrome: An update based on meta‐analysis of randomized control trials. Health Sci Rep. 2022;5(5):e814 (Sep 12). Doi: 10.1002/hsr2.814

Key clinical point: Fecal microbiota transfer (FMT) did not appear to be an effective treatment for irritable bowel syndrome (IBS) symptoms whether administered orally or via colonoscopy, gastroscopy, or a nasojejunal tube, with initial improvements wearing off drastically over time.

Major finding: Despite a significant improvement in the quality-of-life score in the FMT vs control group (mean difference 9.32; P = .0005), the overall change in IBS symptom severity score (P = .67) and the number of respondents considering all routes of administration (P = .19) were not significantly different between treatment arms.

Study details: Findings are from a meta-analysis of eight randomized controlled trials including 472 patients with IBS who received either FMT or autologous transfer/placebo (control group).

Disclosures: This study did not declare any source of funding. The authors declared no conflicts of interest.

Source: Abdelghafar YA et al. Efficacy and safety of fecal microbiota transplant in irritable bowel syndrome: An update based on meta‐analysis of randomized control trials. Health Sci Rep. 2022;5(5):e814 (Sep 12). Doi: 10.1002/hsr2.814

Key clinical point: Disgust sensitivity may act as a potential trigger or predisposition factor for irritable bowel syndrome (IBS), particularly in women.

Major finding: Disgust sensitivity was positively correlated with IBS (correlation coefficient [r] 0.251; P = .014), with the correlation being significant in women (P = .021) but not in men (P = .505). No correlation was observed between IBS and disgust propensity (P = .911) or total disgust score (P = .115).

Study details: This study included 105 healthy participants who completed the Disgust Propensity and Sensitivity Scale-Revised, IBS-Quality of Life Measure, and Chronic Urticaria-Quality of Life Measure questionnaires.

Disclosures: This study did not receive any funding. The authors declared no conflicts of interest.

Source: Formica S et al. Relationship between sensitivity to disgust and irritable bowel syndrome: A study on healthy individuals. Clin Neuropsychiatry. 2022;19(4):230-235 (Aug). Doi: 10.36131/cnfioritieditore20220405

Key clinical point: Disgust sensitivity may act as a potential trigger or predisposition factor for irritable bowel syndrome (IBS), particularly in women.

Major finding: Disgust sensitivity was positively correlated with IBS (correlation coefficient [r] 0.251; P = .014), with the correlation being significant in women (P = .021) but not in men (P = .505). No correlation was observed between IBS and disgust propensity (P = .911) or total disgust score (P = .115).

Study details: This study included 105 healthy participants who completed the Disgust Propensity and Sensitivity Scale-Revised, IBS-Quality of Life Measure, and Chronic Urticaria-Quality of Life Measure questionnaires.

Disclosures: This study did not receive any funding. The authors declared no conflicts of interest.

Source: Formica S et al. Relationship between sensitivity to disgust and irritable bowel syndrome: A study on healthy individuals. Clin Neuropsychiatry. 2022;19(4):230-235 (Aug). Doi: 10.36131/cnfioritieditore20220405

Key clinical point: Disgust sensitivity may act as a potential trigger or predisposition factor for irritable bowel syndrome (IBS), particularly in women.

Major finding: Disgust sensitivity was positively correlated with IBS (correlation coefficient [r] 0.251; P = .014), with the correlation being significant in women (P = .021) but not in men (P = .505). No correlation was observed between IBS and disgust propensity (P = .911) or total disgust score (P = .115).

Study details: This study included 105 healthy participants who completed the Disgust Propensity and Sensitivity Scale-Revised, IBS-Quality of Life Measure, and Chronic Urticaria-Quality of Life Measure questionnaires.

Disclosures: This study did not receive any funding. The authors declared no conflicts of interest.

Source: Formica S et al. Relationship between sensitivity to disgust and irritable bowel syndrome: A study on healthy individuals. Clin Neuropsychiatry. 2022;19(4):230-235 (Aug). Doi: 10.36131/cnfioritieditore20220405

Key clinical point: Cimetropium, drotaverine, and acupuncture were more effective in improving abdominal pain than placebo in patients with irritable bowel syndrome (IBS), with acupuncture being more effective than pinaverium in relieving global IBS symptoms and causing fewer adverse events than other antispasmodics.

Major finding: Cimetropium (standardized mean difference [SMD] −3.00; 95% CI −4.47 to −1.53) was the most effective for relieving abdominal pain, with drotaverine, acupuncture, and pinaverium being superior to placebo. Acupuncture vs pinaverium more effectively relieved global IBS symptoms (SMD −1.11; 95% CI −1.94 to −0.28). The adverse event rate was lower with acupuncture vs most antispasmodics.

Study details: The data come from an adjusted indirect treatment comparison meta-analysis of 35 randomized control trials including 5190 participants.

Disclosures: This study was supported by the National Key Research and Development Program of the Ministry of Science and Technology of the People’s Republic of China and others. The authors declared no conflicts of interest.

Source: Shi YZ et al. Acupuncture vs antispasmodics in the treatment of irritable bowel syndrome: An adjusted indirect treatment comparison meta-analysis. Front Physiol. 2022; 13:1001978 (Oct 6). Doi: 10.3389/fphys.2022.1001978

Key clinical point: Cimetropium, drotaverine, and acupuncture were more effective in improving abdominal pain than placebo in patients with irritable bowel syndrome (IBS), with acupuncture being more effective than pinaverium in relieving global IBS symptoms and causing fewer adverse events than other antispasmodics.

Major finding: Cimetropium (standardized mean difference [SMD] −3.00; 95% CI −4.47 to −1.53) was the most effective for relieving abdominal pain, with drotaverine, acupuncture, and pinaverium being superior to placebo. Acupuncture vs pinaverium more effectively relieved global IBS symptoms (SMD −1.11; 95% CI −1.94 to −0.28). The adverse event rate was lower with acupuncture vs most antispasmodics.

Study details: The data come from an adjusted indirect treatment comparison meta-analysis of 35 randomized control trials including 5190 participants.

Disclosures: This study was supported by the National Key Research and Development Program of the Ministry of Science and Technology of the People’s Republic of China and others. The authors declared no conflicts of interest.

Source: Shi YZ et al. Acupuncture vs antispasmodics in the treatment of irritable bowel syndrome: An adjusted indirect treatment comparison meta-analysis. Front Physiol. 2022; 13:1001978 (Oct 6). Doi: 10.3389/fphys.2022.1001978

Key clinical point: Cimetropium, drotaverine, and acupuncture were more effective in improving abdominal pain than placebo in patients with irritable bowel syndrome (IBS), with acupuncture being more effective than pinaverium in relieving global IBS symptoms and causing fewer adverse events than other antispasmodics.

Major finding: Cimetropium (standardized mean difference [SMD] −3.00; 95% CI −4.47 to −1.53) was the most effective for relieving abdominal pain, with drotaverine, acupuncture, and pinaverium being superior to placebo. Acupuncture vs pinaverium more effectively relieved global IBS symptoms (SMD −1.11; 95% CI −1.94 to −0.28). The adverse event rate was lower with acupuncture vs most antispasmodics.

Study details: The data come from an adjusted indirect treatment comparison meta-analysis of 35 randomized control trials including 5190 participants.

Disclosures: This study was supported by the National Key Research and Development Program of the Ministry of Science and Technology of the People’s Republic of China and others. The authors declared no conflicts of interest.

Source: Shi YZ et al. Acupuncture vs antispasmodics in the treatment of irritable bowel syndrome: An adjusted indirect treatment comparison meta-analysis. Front Physiol. 2022; 13:1001978 (Oct 6). Doi: 10.3389/fphys.2022.1001978

Key clinical point: Treatment with anaerobically cultivated human intestinal microbiota (ACHIM) suspension or donor fecal microbiota transplantation (donor-FMT) but not placebo changed gut microbiota profiles in patients with irritable bowel syndrome (IBS) to those measured in healthy control individuals along with significant changes in bacterial strain signal.

Major finding: Patients receiving donor-FMT vs placebo had more significant bacterial strain signals for Actinobacteria spp. and Bifidobacteria spp., whereas those receiving ACHIM or donor-FMT vs placebo had more significant signals for Alistipes onderdonkii (all P < .05). After receiving ACHIM suspension or donor-FMT, but not placebo, the bacterial signal in patients resembled more that in healthy controls. No post-transplant complications were reported.

Study details: The data come from a randomized controlled study including 43 patients with IBS-D who received ACHIM suspension (n = 17), donor-FMT (n = 11), or placebo (patient’s own feces; n = 15).

Disclosures: This study was funded by Helse Vest, Norway. The authors declared no conflicts of interest.

Source: Mazzawi T et al. The effect of anaerobically cultivated human intestinal microbiota compared to fecal microbiota transplantation on gut microbiota profile and symptoms of irritable bowel syndrome, a double-blind placebo-controlled study. Microorganisms. 2022;10(9):1819 (Sep 11). Doi: 10.3390/microorganisms10091819

Key clinical point: Treatment with anaerobically cultivated human intestinal microbiota (ACHIM) suspension or donor fecal microbiota transplantation (donor-FMT) but not placebo changed gut microbiota profiles in patients with irritable bowel syndrome (IBS) to those measured in healthy control individuals along with significant changes in bacterial strain signal.

Major finding: Patients receiving donor-FMT vs placebo had more significant bacterial strain signals for Actinobacteria spp. and Bifidobacteria spp., whereas those receiving ACHIM or donor-FMT vs placebo had more significant signals for Alistipes onderdonkii (all P < .05). After receiving ACHIM suspension or donor-FMT, but not placebo, the bacterial signal in patients resembled more that in healthy controls. No post-transplant complications were reported.

Study details: The data come from a randomized controlled study including 43 patients with IBS-D who received ACHIM suspension (n = 17), donor-FMT (n = 11), or placebo (patient’s own feces; n = 15).

Disclosures: This study was funded by Helse Vest, Norway. The authors declared no conflicts of interest.

Source: Mazzawi T et al. The effect of anaerobically cultivated human intestinal microbiota compared to fecal microbiota transplantation on gut microbiota profile and symptoms of irritable bowel syndrome, a double-blind placebo-controlled study. Microorganisms. 2022;10(9):1819 (Sep 11). Doi: 10.3390/microorganisms10091819

Key clinical point: Treatment with anaerobically cultivated human intestinal microbiota (ACHIM) suspension or donor fecal microbiota transplantation (donor-FMT) but not placebo changed gut microbiota profiles in patients with irritable bowel syndrome (IBS) to those measured in healthy control individuals along with significant changes in bacterial strain signal.

Major finding: Patients receiving donor-FMT vs placebo had more significant bacterial strain signals for Actinobacteria spp. and Bifidobacteria spp., whereas those receiving ACHIM or donor-FMT vs placebo had more significant signals for Alistipes onderdonkii (all P < .05). After receiving ACHIM suspension or donor-FMT, but not placebo, the bacterial signal in patients resembled more that in healthy controls. No post-transplant complications were reported.

Study details: The data come from a randomized controlled study including 43 patients with IBS-D who received ACHIM suspension (n = 17), donor-FMT (n = 11), or placebo (patient’s own feces; n = 15).

Disclosures: This study was funded by Helse Vest, Norway. The authors declared no conflicts of interest.

Source: Mazzawi T et al. The effect of anaerobically cultivated human intestinal microbiota compared to fecal microbiota transplantation on gut microbiota profile and symptoms of irritable bowel syndrome, a double-blind placebo-controlled study. Microorganisms. 2022;10(9):1819 (Sep 11). Doi: 10.3390/microorganisms10091819

Key clinical point: Modest conformation exists between subjective reporting of the Bristol Stool Form Scale (BSFS) and fecal consistency measured by stool water content in irritable bowel syndrome (IBS), warranting caution when using BSFS reporting for subtyping IBS.

Major finding: BSFS scores significantly correlated with stool water content (correlation coefficient [r] 0.36, P < .0001); however, 77% of stool samples referred as BSFS 1-2 had a water content of ≤68.5% and 52.0% of samples referred as BSFS 6-7 had a water content of ≥78%. Sensitivity and specificity for BSFS 1-2 were 32% and 94%, respectively, and those for BSFS 6-7 were 37% and 93%, respectively.

Study details: The data come from a subanalysis of a previous randomized three-way crossover trial including 110 participants with severe-to-moderate IBS who underwent 1-week provocation with fermentable oligosaccharides, disaccharides, monosaccharides, and polyols; gluten; or placebo.

Disclosures: This study was funded by Formas and the Swedish Research Council. The authors declared no conflicts of interest.

Source: Nordin E et al. Modest conformity between self-reporting of Bristol stool form and fecal consistency measured by stool water content in irritable bowel syndrome, a FODMAP and gluten trial. Am J Gastroenterol. 2022;117(10):1668-1674 (Aug 12). Doi: 10.14309/ajg.0000000000001942

Key clinical point: Modest conformation exists between subjective reporting of the Bristol Stool Form Scale (BSFS) and fecal consistency measured by stool water content in irritable bowel syndrome (IBS), warranting caution when using BSFS reporting for subtyping IBS.

Major finding: BSFS scores significantly correlated with stool water content (correlation coefficient [r] 0.36, P < .0001); however, 77% of stool samples referred as BSFS 1-2 had a water content of ≤68.5% and 52.0% of samples referred as BSFS 6-7 had a water content of ≥78%. Sensitivity and specificity for BSFS 1-2 were 32% and 94%, respectively, and those for BSFS 6-7 were 37% and 93%, respectively.

Study details: The data come from a subanalysis of a previous randomized three-way crossover trial including 110 participants with severe-to-moderate IBS who underwent 1-week provocation with fermentable oligosaccharides, disaccharides, monosaccharides, and polyols; gluten; or placebo.

Disclosures: This study was funded by Formas and the Swedish Research Council. The authors declared no conflicts of interest.

Source: Nordin E et al. Modest conformity between self-reporting of Bristol stool form and fecal consistency measured by stool water content in irritable bowel syndrome, a FODMAP and gluten trial. Am J Gastroenterol. 2022;117(10):1668-1674 (Aug 12). Doi: 10.14309/ajg.0000000000001942

Key clinical point: Modest conformation exists between subjective reporting of the Bristol Stool Form Scale (BSFS) and fecal consistency measured by stool water content in irritable bowel syndrome (IBS), warranting caution when using BSFS reporting for subtyping IBS.

Major finding: BSFS scores significantly correlated with stool water content (correlation coefficient [r] 0.36, P < .0001); however, 77% of stool samples referred as BSFS 1-2 had a water content of ≤68.5% and 52.0% of samples referred as BSFS 6-7 had a water content of ≥78%. Sensitivity and specificity for BSFS 1-2 were 32% and 94%, respectively, and those for BSFS 6-7 were 37% and 93%, respectively.

Study details: The data come from a subanalysis of a previous randomized three-way crossover trial including 110 participants with severe-to-moderate IBS who underwent 1-week provocation with fermentable oligosaccharides, disaccharides, monosaccharides, and polyols; gluten; or placebo.

Disclosures: This study was funded by Formas and the Swedish Research Council. The authors declared no conflicts of interest.

Source: Nordin E et al. Modest conformity between self-reporting of Bristol stool form and fecal consistency measured by stool water content in irritable bowel syndrome, a FODMAP and gluten trial. Am J Gastroenterol. 2022;117(10):1668-1674 (Aug 12). Doi: 10.14309/ajg.0000000000001942

Key clinical point: Bowel symptoms and psychosocial features were not significantly different among patients with irritable bowel syndrome (IBS) who experienced only pain (Rome IV criteria) or discomfort (seen in Rome III but not Rome IV criteria) as the predominant abdominal symptom associated with defecation.

Major finding: Overall, 33.8% of patients who met the Rome III criteria for IBS failed to meet the Rome IV criteria. Bowel habits, coexisting extragastrointestinal pain, comorbid anxiety, depression, and IBS quality-of-life scores were not significantly different between patients with pain and those with discomfort.

Study details: This study included 367 patients who met the Rome III criteria for IBS; patients were categorized into the only pain (n = 233), only discomfort (n = 83), or pain and discomfort (n = 51) group according to the predominant abdominal symptom associated with defecation.

Disclosures: This study was supported by the Program of International S & T Cooperation, the National Natural Science Foundation of China, and others. The authors declared no conflicts of interest.

Source: Fang XC et al. Are bowel symptoms and psychosocial features different in irritable bowel syndrome patients with abdominal discomfort compared to abdominal pain? World J Gastroenterol. 2022;28(33):4861-4874 (Sep 7). Doi: 10.3748/wjg.v28.i33.4861

Key clinical point: Bowel symptoms and psychosocial features were not significantly different among patients with irritable bowel syndrome (IBS) who experienced only pain (Rome IV criteria) or discomfort (seen in Rome III but not Rome IV criteria) as the predominant abdominal symptom associated with defecation.

Major finding: Overall, 33.8% of patients who met the Rome III criteria for IBS failed to meet the Rome IV criteria. Bowel habits, coexisting extragastrointestinal pain, comorbid anxiety, depression, and IBS quality-of-life scores were not significantly different between patients with pain and those with discomfort.

Study details: This study included 367 patients who met the Rome III criteria for IBS; patients were categorized into the only pain (n = 233), only discomfort (n = 83), or pain and discomfort (n = 51) group according to the predominant abdominal symptom associated with defecation.

Disclosures: This study was supported by the Program of International S & T Cooperation, the National Natural Science Foundation of China, and others. The authors declared no conflicts of interest.

Source: Fang XC et al. Are bowel symptoms and psychosocial features different in irritable bowel syndrome patients with abdominal discomfort compared to abdominal pain? World J Gastroenterol. 2022;28(33):4861-4874 (Sep 7). Doi: 10.3748/wjg.v28.i33.4861

Key clinical point: Bowel symptoms and psychosocial features were not significantly different among patients with irritable bowel syndrome (IBS) who experienced only pain (Rome IV criteria) or discomfort (seen in Rome III but not Rome IV criteria) as the predominant abdominal symptom associated with defecation.

Major finding: Overall, 33.8% of patients who met the Rome III criteria for IBS failed to meet the Rome IV criteria. Bowel habits, coexisting extragastrointestinal pain, comorbid anxiety, depression, and IBS quality-of-life scores were not significantly different between patients with pain and those with discomfort.

Study details: This study included 367 patients who met the Rome III criteria for IBS; patients were categorized into the only pain (n = 233), only discomfort (n = 83), or pain and discomfort (n = 51) group according to the predominant abdominal symptom associated with defecation.

Disclosures: This study was supported by the Program of International S & T Cooperation, the National Natural Science Foundation of China, and others. The authors declared no conflicts of interest.

Source: Fang XC et al. Are bowel symptoms and psychosocial features different in irritable bowel syndrome patients with abdominal discomfort compared to abdominal pain? World J Gastroenterol. 2022;28(33):4861-4874 (Sep 7). Doi: 10.3748/wjg.v28.i33.4861