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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 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.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02782325
The ClinicalTrials.gov registry entry for NCT02782325 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 6 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of North Carolina, Chapel Hill, which has 1,109 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Active FMT, then open label FMT is the first listed.
NCT02782325 reports 0 study locations.
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.
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