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NCT02782325 · ClinicalTrials.gov registry record · Phase 1
Safety and Efficacy of Fecal Microbiome Transplantation (FMT) in the Treatment of Antibiotic Dependent Pouchitis (ADP)
A Phase 1 study, sponsored by University of North Carolina, Chapel Hill.
- Terminated
- Registry status
- Phase 1
- Development phase
- 6
- Enrollment target
NCT02782325: Clinical Trial Phase 1 study, sponsored by University of North Carolina, Chapel Hill.
NCT02782325 is a Phase 1 study that was terminated before completion, run by University of North Carolina, Chapel Hill. The registered enrollment target is 6 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02782325, a Phase 1 study, was terminated before completion, sponsored by University of North Carolina, Chapel Hill.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 6 participants
- Enrollment target
Study Summary
Antibiotic dependent pouchitis (ADP) is predestined to benefit from FMT, since bacterial dysbiosis, which can only be controlled with antibiotics, appears to be the major driver of the clinical symptoms. This is a proof of concept randomized placebo controlled trial, in which 50% of the patients will receive FMT and 50% will receive a placebo FMT. Additionally the trial offers an open label extension period.
Primary Outcome
Number of patients with FMT related adverse event (classified according to MedDRA; lowest level term) and categorized according to CTCAE Version 4.0. The safety was assessed in the randomized placebo controlled segment of the study over 24 weeks after initial endoscopic FMT weeks and if the patient should enter the open label extension part of the study also for 24 weeks after initial open label FMT. 6 patients participated in the randomized arm and 5 patients in the open label extension arm.
Interventions
- BIOLOGICAL Active FMT, then open label FMT
- BIOLOGICAL Placebo FMT, then open label FMT
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2017-06-01 |
| Est. Completion | 2018-12-03 |
| Phase | Phase 1 |
Why NCT02782325 stopped before completion
NCT02782325 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 2 interventions - of which Active FMT, then open label FMT is the first listed.
NCT02782325 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02782325 about?
NCT02782325 is a clinical study titled "Safety and Efficacy of Fecal Microbiome Transplantation (FMT) in the Treatment of Antibiotic Dependent Pouchitis (ADP)". Antibiotic dependent pouchitis (ADP) is predestined to benefit from FMT, since bacterial dysbiosis, which can only be controlled with antibiotics, appears to be the major driver of the clinical symptoms. This is a proof of concept randomized placebo controlled trial, in which 50% of the patients wil...
What is the current status of trial NCT02782325?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 6 participants. The study started on 2017-06-01. Estimated completion is 2018-12-03.
What interventions are being tested in trial NCT02782325?
The interventions under investigation include: Active FMT, then open label FMT (BIOLOGICAL), Placebo FMT, then open label FMT (BIOLOGICAL).
Who is sponsoring clinical trial NCT02782325?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02782325's enrollment target sits among peer trials
6 1974th of 2000 higher than 12 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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