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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. 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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02343328
The ClinicalTrials.gov registry entry for NCT02343328 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 3 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Massachusetts General Hospital, which has 2,032 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02343328 reports 0 study locations.
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.
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