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NCT02828384 · ClinicalTrials.gov registry record · Phase 2
Comparing the Effectiveness of Two Dietary Interventions for Fecal Incontinence
A Phase 2 study, sponsored by University of Michigan.
- Completed
- Registry status
- Phase 2
- Development phase
- 40
- Enrollment target
NCT02828384: Completed Phase 2 study, sponsored by University of Michigan.
NCT02828384 is a Phase 2 study that has completed, run by University of Michigan. The registered enrollment target is 40 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02828384, a Phase 2 study, has completed, sponsored by University of Michigan.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 40 participants
- Enrollment target
Study Summary
Background: Fecal incontinence (FI) is a common complaint, and is often associated with diarrhea and urgency. Foods that are high in fermentable oligo-, di-, and mono-saccharides and polyols (FODMAPs) cause symptoms of diarrhea and urgency. Thus, assessing the impact of a low FODMAP diet in FI patients is needed. Aims: 1. Compare the treatment response with a low FODMAP vs. psyllium based on number of episodes in patients with FI. 2. Compare the efficacy of a low FODMAP diet vs. psyllium in patients with FI on pre-specified clinical and quality of life endpoints. Methods: This is a prospective, randomized control trial of adults meeting the Rome III criteria for FI and at least 1 episode of FI due to loose stool per week. After a 2 week screening period and randomization, during which the severity of symptoms will be assessed and eligibility determined, patients will be randomized to psyllium vs. low FODMAP diet for 4 weeks. A total of 20 patients will be recruited for each arm. The primary endpoint will be treatment response based on number of incontinence episodes. A treatment response is defined as a reduction in the number of FI episodes/week.
Primary Outcome
Will compare baseline number of FI episodes to number of FI episodes at week 4
Interventions
- DIETARY_SUPPLEMENT Psyllium
- OTHER low fodmap diet
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2014-10-02 |
| Est. Completion | 2019-06 |
| Phase | Phase 2 |
What the finished NCT02828384 record still lists
NCT02828384 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (70% lower).
The record links to 0 conditions, and to 2 interventions - of which Psyllium is the first listed.
NCT02828384 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02828384 about?
NCT02828384 is a clinical study titled "Comparing the Effectiveness of Two Dietary Interventions for Fecal Incontinence". Background: Fecal incontinence (FI) is a common complaint, and is often associated with diarrhea and urgency. Foods that are high in fermentable oligo-, di-, and mono-saccharides and polyols (FODMAPs) cause symptoms of diarrhea and urgency. Thus, assessing the impact of a low FODMAP diet in FI pati...
What is the current status of trial NCT02828384?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2014-10-02. Estimated completion is 2019-06.
What interventions are being tested in trial NCT02828384?
The interventions under investigation include: Psyllium (DIETARY_SUPPLEMENT), low fodmap diet (OTHER).
Who is sponsoring clinical trial NCT02828384?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02828384's enrollment target sits among peer trials
40 1362nd of 2000 higher than 542 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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