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NCT02343328 · ClinicalTrials.gov registry record · Phase 1
Placebo Controlled Study of Fecal Microbiota Transplant (FMT) for a First or Second Episode of C. Difficile Infection in Adults Using a Frozen Encapsulated Inoculum
A Phase 1 study, sponsored by Massachusetts General Hospital.
- Terminated
- Registry status
- Phase 1
- Development phase
- 3
- Enrollment target
NCT02343328: Clinical Trial Phase 1 study, sponsored by Massachusetts General Hospital.
NCT02343328 is a Phase 1 study that was terminated before completion, run by Massachusetts General Hospital. The registered enrollment target is 3 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02343328, a Phase 1 study, was terminated before completion, sponsored by Massachusetts General Hospital.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 3 participants
- Enrollment target
Study Summary
The investigators wish to compare Fecal Microbiota Transplant (FMT) capsules to placebo capsules in subjects with TWO episodes of C. difficile. The investigators have numerous subjects and physicians requesting FMT at the time of a second relapse, in order to prevent further hospitalizations, obtain a faster and more durable cure, avoid costly medications like fidaxomicin and oral vancomycin, and "fix" the underlying dysbiosis. In some instances, subjects feel like they are being asked to "get sick again" before they can pursue the most effective option. The investigators propose to study these subjects with a rigorous placebo controlled design, which will contribute significantly to our understanding of the utility of FMT, timing, and the real relapse rates in a tertiary referral center. Subjects who relapse with placebo will by definition have a third episode, meet consensus criteria for FMT, and will be offered "standard" FMT by capsule at that time. Additionally, this study will allow us to further capture safety data, in comparison to placebo capsules and further enhance our understanding of the microbiology of dysbiosis, earlier on in the illness course. Lastly, the investigators may decide to perform a cost analysis.
Primary Outcome
The primary objective of this study is to evaluate the safety and efficacy of FMT, and the relapse rate compared to placebo at 8 weeks, with cure defined by the absence of diarrhea/CDI symptoms at 8 weeks. We are defining the absence of relapsed CDI at 8 weeks symptoms as a cure.
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL Fecal Microbiota Transplant
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2015-01 |
| Est. Completion | 2016-07-29 |
| Phase | Phase 1 |
Why NCT02343328 stopped before completion
NCT02343328 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02343328 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02343328 about?
NCT02343328 is a clinical study titled "Placebo Controlled Study of Fecal Microbiota Transplant (FMT) for a First or Second Episode of C. Difficile Infection in Adults Using a Frozen Encapsulated Inoculum". The investigators wish to compare Fecal Microbiota Transplant (FMT) capsules to placebo capsules in subjects with TWO episodes of C. difficile. The investigators have numerous subjects and physicians requesting FMT at the time of a second relapse, in order to prevent further hospitalizations, obtain...
What is the current status of trial NCT02343328?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 3 participants. The study started on 2015-01. Estimated completion is 2016-07-29.
What interventions are being tested in trial NCT02343328?
The interventions under investigation include: Placebo (BIOLOGICAL), Fecal Microbiota Transplant (BIOLOGICAL).
Who is sponsoring clinical trial NCT02343328?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02343328's enrollment target sits among peer trials
3 1999th of 2000 higher than 1 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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