Irritable Bowel Syndrome Clinical Trial
Official title:
A Longitudinal Study to Identify IBS Phenotypes Using Fecal Microbiota and Hydrogen Breath Testing
Verified date | April 2024 |
Source | University of Michigan |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Diarrhea-predominant irritable bowel syndrome (IBS-D) is a highly prevalent but poorly understood condition with limited treatment options. Current therapies, including a nonabsorbable antibiotic rifaximin or diet low in fermentable oligosaccharides, disaccharides, monosaccharides, and polyols (FODMAP), show efficacy in 50% or less of patients. In this proposal, we will randomize IBS-D patients to receive either rifaximin or low FODMAP dietary intervention.
Status | Completed |
Enrollment | 64 |
Est. completion date | February 28, 2024 |
Est. primary completion date | February 28, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: Adult subjects greater than or equal to 18 years of age who meet Rome IV criteria for diarrhea-predominant irritable bowel syndrome (IBS-D). Prior colonoscopy or sigmoidoscopy within the past 2 years with random colon biopsies to exclude the presence of microscopic colitis. IBS medications, including anti-depressants, will be allowed if the dose has been stable for at least 1 month before inclusion. Medications will be carefully tracked to follow any potential confounding issues. Exclusion Criteria: Underlying celiac disease, inflammatory bowel disease, or other organic disease that could explain their symptoms. Subjects with a history of GI tract surgery, except for cholecystectomy or appendectomy, will also be excluded from the study. Women who are pregnant or breastfeeding Antibiotics taken within 3 months prior to enrollment will not be permitted. Subjects on probiotics must discontinue their use at least 1 month prior to enrollment. Subjects who have previously received formal dietary education for IBS, including a low FODMAP diet, or previously received antibiotics, including rifaximin, for treatment of IBS-D will be excluded from the study. |
Country | Name | City | State |
---|---|---|---|
United States | University of Michigan | Ann Arbor | Michigan |
Lead Sponsor | Collaborator |
---|---|
University of Michigan | Michigan Institute for Clinical and Health Research (MICHR) |
United States,
Bohn L, Storsrud S, Liljebo T, Collin L, Lindfors P, Tornblom H, Simren M. Diet low in FODMAPs reduces symptoms of irritable bowel syndrome as well as traditional dietary advice: a randomized controlled trial. Gastroenterology. 2015 Nov;149(6):1399-1407.e2. doi: 10.1053/j.gastro.2015.07.054. Epub 2015 Aug 5. — View Citation
Eswaran SL, Chey WD, Han-Markey T, Ball S, Jackson K. A Randomized Controlled Trial Comparing the Low FODMAP Diet vs. Modified NICE Guidelines in US Adults with IBS-D. Am J Gastroenterol. 2016 Dec;111(12):1824-1832. doi: 10.1038/ajg.2016.434. Epub 2016 Oct 11. — View Citation
Lembo A, Pimentel M, Rao SS, Schoenfeld P, Cash B, Weinstock LB, Paterson C, Bortey E, Forbes WP. Repeat Treatment With Rifaximin Is Safe and Effective in Patients With Diarrhea-Predominant Irritable Bowel Syndrome. Gastroenterology. 2016 Dec;151(6):1113-1121. doi: 10.1053/j.gastro.2016.08.003. Epub 2016 Aug 13. — View Citation
Pimentel M, Lembo A, Chey WD, Zakko S, Ringel Y, Yu J, Mareya SM, Shaw AL, Bortey E, Forbes WP; TARGET Study Group. Rifaximin therapy for patients with irritable bowel syndrome without constipation. N Engl J Med. 2011 Jan 6;364(1):22-32. doi: 10.1056/NEJMoa1004409. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Glucose Breath Tests | Glucose breath tests (GBT) will be performed at baseline and repeated after intervention | 4 weeks | |
Other | Fecal Microbiota | Changes in fecal microbial diversity after intervention will be compared with baseline. | 4 weeks | |
Primary | Improvement in Mean Daily Pain and/or Bloating | The primary outcome will be changes in mean daily pain or bloating by visual analog scale (VAS) after intervention compared with baseline. Responders to intervention will be defined by = 30% reductions in mean daily pain or bloating by VAS compared with baseline. | 4 weeks | |
Secondary | IBS Symptom Severity Scale | Secondary outcomes will be defined by reduction in IBS Symptom Severity Scale by = 50 compared with baseline. | 4 weeks |
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