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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 is a Phase 2 study that has completed, run by University of Michigan. The registered enrollment target is 40 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02828384
The ClinicalTrials.gov registry entry for NCT02828384 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Michigan, which has 1,327 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Psyllium is the first listed.
NCT02828384 reports 0 study locations.
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.
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