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NCT02403622 · ClinicalTrials.gov registry record · Phase 2
Safety of FMT: OpenBiome Outcomes and Longitudinal Follow-up (STOOL) for Recurrent Clostridium Difficile Infection
A Phase 2 study, sponsored by Microbiome Health Research Institute.
- Terminated
- Registry status
- Phase 2
- Development phase
- 17
- Enrollment target
NCT02403622: Clinical Trial Phase 2 study, sponsored by Microbiome Health Research Institute.
NCT02403622 is a Phase 2 study that was terminated before completion, run by Microbiome Health Research Institute. The registered enrollment target is 17 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02403622, a Phase 2 study, was terminated before completion, sponsored by Microbiome Health Research Institute.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 17 participants
- Enrollment target
Study Summary
The overarching objective of this study is to address the knowledge gap regarding the short-term and long-term safety of fecal microbiota transplants (FMT). The design will be a prospective, open-label, multi-center longitudinal cohort study to assess the short- and long-term safety of FMT as well as the clinical resolution of diarrhea among 150 patients with 3 or more episodes of clostridium difficile infection (CDI defined as 3 unformed stools over 24 hours for 2 consecutive days and either a positive stool test for CDI or pseudomembranes on colonoscopy/sigmoidoscopy). Subjects will be adult outpatients referred to one of the study centers after at least three recurrent episodes of CDI and previous treatment with at least one 10-day course of oral vancomycin or fidaxomicin. After FMT by colonoscopy/sigmoidoscopy or enema, patients will be followed prospectively and monitored for clinical resolution and adverse events at: 3 days (telephone), 3 weeks (clinical assessment), 8 weeks (telephone), 6 months (telephone), and 12 months (telephone) after FMT. Subjects who recur will be offered a second FMT by colonoscopy with a different donor. Microbiome analysis will be conducted from stool samples at baseline and each of the 5 follow-up intervals.
Primary Outcome
Determine the short-term safety of FMT for the prevention of further CDI recurrence. Short-term safety was measured by absence or presence of related serious adverse events
Interventions
- DRUG Fecal Microbiota Preparation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2015-03 |
| Est. Completion | 2018-06 |
| Phase | Phase 2 |
Why NCT02403622 stopped before completion
NCT02403622 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 1 intervention - of which Fecal Microbiota Preparation is the first listed.
NCT02403622 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02403622 about?
NCT02403622 is a clinical study titled "Safety of FMT: OpenBiome Outcomes and Longitudinal Follow-up (STOOL) for Recurrent Clostridium Difficile Infection". The overarching objective of this study is to address the knowledge gap regarding the short-term and long-term safety of fecal microbiota transplants (FMT). The design will be a prospective, open-label, multi-center longitudinal cohort study to assess the short- and long-term safety of FMT as well a...
What is the current status of trial NCT02403622?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 17 participants. The study started on 2015-03. Estimated completion is 2018-06.
What interventions are being tested in trial NCT02403622?
The interventions under investigation include: Fecal Microbiota Preparation (DRUG).
Who is sponsoring clinical trial NCT02403622?
This trial is sponsored by Microbiome Health Research Institute, which has 3 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02403622's enrollment target sits among peer trials
17 1903rd of 2000 higher than 93 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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