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NCT03219528 · ClinicalTrials.gov registry record · Phase 4
A Longitudinal Study to Identify IBS Phenotypes Using Fecal Microbiota and Hydrogen Breath Testing
A Phase 4 study of Irritable Bowel Syndrome, sponsored by University of Michigan.
- Completed
- Registry status
- Phase 4
- Development phase
- 74
- Enrollment target
- 1
- Study location
NCT03219528: Completed Phase 4 study of Irritable Bowel Syndrome, sponsored by University of Michigan.
NCT03219528 is a Phase 4 study of Irritable Bowel Syndrome that has completed, run by University of Michigan. The registered enrollment target is 74 participants, below the 143-participant average among 47 other Irritable Bowel Syndrome trials with a reported enrollment target (48% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03219528, a Phase 4 study of Irritable Bowel Syndrome, has completed, sponsored by University of Michigan.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 74 participants
- Enrollment target
- 1
- Study location
Study Summary
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, participants with IBS-D will be randomized to receive either rifaximin or low FODMAP dietary intervention.
Primary Outcome
Change in mean daily abdominal pain was measured using a visual analog scale (VAS) after intervention compared with baseline. VAS was a scale of 0 to 10, with higher numbers indicating a higher degree of pain; 0 indicated no pain and 10 indicated severe pain.
Conditions Studied
Interventions
- OTHER Low FODMAP Diet
- DRUG Rifaximin 550 MG
Study Locations (1)
Michigan
- University of Michigan - Ann Arbor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 74 participants |
| Start Date | 2018-02-13 |
| Est. Completion | 2024-02-28 |
| Phase | Phase 4 |
What the finished NCT03219528 record still lists
NCT03219528 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 74 participants, a relatively small participant target, below the 143-participant average among 47 other Irritable Bowel Syndrome trials with a reported enrollment target (48% lower).
The record links to 1 condition, with Irritable Bowel Syndrome appearing as the primary indexed condition, and to 2 interventions - of which Low FODMAP Diet is the first listed.
NCT03219528 reports a single indexed study location in Michigan.
Frequently Asked Questions
What is clinical trial NCT03219528 about?
NCT03219528 is a clinical study titled "A Longitudinal Study to Identify IBS Phenotypes Using Fecal Microbiota and Hydrogen Breath Testing". 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 (FODM...
What is the current status of trial NCT03219528?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 74 participants. The study started on 2018-02-13. Estimated completion is 2024-02-28.
What conditions does trial NCT03219528 study?
This clinical trial studies the following conditions: Irritable Bowel Syndrome.
What interventions are being tested in trial NCT03219528?
The interventions under investigation include: Low FODMAP Diet (OTHER), Rifaximin 550 MG (DRUG).
Who is sponsoring clinical trial NCT03219528?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03219528 being conducted?
This trial has 1 study location across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Irritable Bowel Syndrome
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03219528's enrollment target sits among peer trials
74 27th of 47 higher than 21 of 47 other Irritable Bowel Syndrome trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Irritable Bowel Syndrome trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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