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NCT02328547 · ClinicalTrials.gov registry record · Phase 2
Fecal Microbiota Transplantation for the Treatment of Diarrhea-Predominant Irritable Bowel Syndrome
A Phase 2 study, sponsored by Montefiore Medical Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 48
- Enrollment target
NCT02328547: Completed Phase 2 study, sponsored by Montefiore Medical Center.
NCT02328547 is a Phase 2 study that has completed, run by Montefiore Medical Center. The registered enrollment target is 48 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (64% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02328547, a Phase 2 study, has completed, sponsored by Montefiore Medical Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 48 participants
- Enrollment target
Study Summary
The objectives of this study are (1) to determine the efficacy of fecal microbiota transplantation (FMT), given as oral capsules, compared with placebo for the treatment of refractory diarrhea-predominant irritable bowel syndrome (IBS-D); (2) determine the impact of FMT on the intestinal microbiome of patients with IBS-D; and (3) assess the safety, feasibility, and tolerability of FMT for patients with IBS-D.
Primary Outcome
Within and between group comparisons of changes (from baseline) in Irritable Bowel Syndrome-Symptom Severity Score (IBS-SSS), obtained via administration of a Questionnaire, for each of the two arms/groups (FMT capsules first, and placebo capsules first). The scale range was 0-500 (min-max). Scores were averaged among time points to yield an overall mean score. Higher scores were indicative of greater disease severity (worse outcome). Subjects were categorized as having mild (75-175), moderate (
Interventions
- DRUG Placebo capsules
- DRUG Fecal microbiota transplantation capsules
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2015-05 |
| Est. Completion | 2018-03 |
| Phase | Phase 2 |
What the finished NCT02328547 record still lists
NCT02328547 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (64% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo capsules is the first listed.
NCT02328547 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02328547 about?
NCT02328547 is a clinical study titled "Fecal Microbiota Transplantation for the Treatment of Diarrhea-Predominant Irritable Bowel Syndrome". The objectives of this study are (1) to determine the efficacy of fecal microbiota transplantation (FMT), given as oral capsules, compared with placebo for the treatment of refractory diarrhea-predominant irritable bowel syndrome (IBS-D); (2) determine the impact of FMT on the intestinal microbiome ...
What is the current status of trial NCT02328547?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 48 participants. The study started on 2015-05. Estimated completion is 2018-03.
What interventions are being tested in trial NCT02328547?
The interventions under investigation include: Placebo capsules (DRUG), Fecal microbiota transplantation capsules (DRUG).
Who is sponsoring clinical trial NCT02328547?
This trial is sponsored by Montefiore Medical Center, which has 345 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02328547's enrollment target sits among peer trials
48 1265th of 2000 higher than 718 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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