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NCT02255305 · ClinicalTrials.gov registry record · Phase 2
FMT Versus Antimicrobials for Initial Treatment of Recurrent CDI
A Phase 2 study, sponsored by Endeavor Health.
- Terminated
- Registry status
- Phase 2
- Development phase
- 6
- Enrollment target
NCT02255305: Clinical Trial Phase 2 study, sponsored by Endeavor Health.
NCT02255305 is a Phase 2 study that was terminated before completion, run by Endeavor Health. The registered enrollment target is 6 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02255305, a Phase 2 study, was terminated before completion, sponsored by Endeavor Health.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 6 participants
- Enrollment target
Study Summary
The purpose of the study is to determine the safety and efficacy of Fecal Microbiota Transplant (FMT) for the treatment of the recurrence of Clostridium difficile infection (CDI) as compared to standard antibiotic therapy. Patients who have tested positive for CDI within 90 days of an admission for relapse of CDI will be approached to participate in this open-label, randomized controlled trial. Patients will either be randomized to the intervention group (receive FMT via retention enema) or the control group (receive antimicrobials targeting CDI).
Primary Outcome
Number of patients with resolution of diarrhea and other abdominal symptoms or return to baseline symptoms that were present prior to C. difficile diagnosis
Interventions
- BIOLOGICAL FMT
- DRUG Antimicrobials
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2015-01 |
| Est. Completion | 2020-01 |
| Phase | Phase 2 |
Why NCT02255305 stopped before completion
NCT02255305 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 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 2 interventions - of which FMT is the first listed.
NCT02255305 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02255305 about?
NCT02255305 is a clinical study titled "FMT Versus Antimicrobials for Initial Treatment of Recurrent CDI". The purpose of the study is to determine the safety and efficacy of Fecal Microbiota Transplant (FMT) for the treatment of the recurrence of Clostridium difficile infection (CDI) as compared to standard antibiotic therapy. Patients who have tested positive for CDI within 90 days of an admission for ...
What is the current status of trial NCT02255305?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 6 participants. The study started on 2015-01. Estimated completion is 2020-01.
What interventions are being tested in trial NCT02255305?
The interventions under investigation include: FMT (BIOLOGICAL), Antimicrobials (DRUG).
Who is sponsoring clinical trial NCT02255305?
This trial is sponsored by Endeavor Health, which has 94 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02255305's enrollment target sits among peer trials
6 1996th of 2000 higher than 1 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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