A Longitudinal Study to Identify IBS Phenotypes Using Fecal Microbiota and Hydrogen Breath Testing
Source: ClinicalTrials.gov NCT03219528 ↗Summary
Linked Publications
-
A Randomized Trial of Rifaximin vs Low Fermentable Oligosaccharides, Disaccharides, Monosaccharides, and Polyols Diet for Symptom Outcomes and Microbiome Changes in Irritable Bowel Syndrome.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Mean Daily Abdominal Pain |
5.2; 5.3; 3.9; 3.8 | 0.78 |
| PRIMARY Change in Mean Daily Bloating |
4.9; 5.1; 4.0; 3.7 | 0.77 |
| SECONDARY Change in Irritable Bowel Syndrome (IBS) Symptom Severity Scale |
281.3; 272.0; 209.3; 194.7 | — |
| SECONDARY Change in Gastrointestinal System Ratings Scale (GSRS) |
52.0; 52.1; 40.7; 40.1 | — |
| SECONDARY Change in Stool Form |
5.6; 5.6; 5.0; 5.3 | — |
| SECONDARY Change in Psychological Function |
8.6; 8.3; 6.2; 5.8 | — |
| SECONDARY Change in Irritable Bowel Syndrome Quality of Life Instrument (IBS-QOL) |
53.6; 58.9; 62.6; 67.8 | — |
| SECONDARY 24-hour Diet Recall/Intake - Lactose |
4.1; 7.3; 5.1; 1.4 | — |
| SECONDARY 24-hour Diet Recall/Intake - Gluten |
6.7; 5.7; 7.2; 1.7 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT03219528) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.