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NCT02403622 · ClinicalTrials.gov registry record · Phase 2
Safety of FMT: OpenBiome Outcomes and Longitudinal Follow-up (STOOL) for Recurrent Clostridium Difficile Infection
A Phase 2 study, sponsored by Microbiome Health Research Institute.
- Terminated
- Registry status
- Phase 2
- Development phase
- 17
- Enrollment target
NCT02403622 is a Phase 2 study that was terminated before completion, run by Microbiome Health Research Institute. The registered enrollment target is 17 participants.
The verdict
NCT02403622, a Phase 2 study, was terminated before completion, sponsored by Microbiome Health Research Institute.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 17 participants
- Enrollment target
Study Summary
The overarching objective of this study is to address the knowledge gap regarding the short-term and long-term safety of fecal microbiota transplants (FMT). The design will be a prospective, open-label, multi-center longitudinal cohort study to assess the short- and long-term safety of FMT as well as the clinical resolution of diarrhea among 150 patients with 3 or more episodes of clostridium difficile infection (CDI defined as 3 unformed stools over 24 hours for 2 consecutive days and either a positive stool test for CDI or pseudomembranes on colonoscopy/sigmoidoscopy). Subjects will be adult outpatients referred to one of the study centers after at least three recurrent episodes of CDI and previous treatment with at least one 10-day course of oral vancomycin or fidaxomicin. After FMT by colonoscopy/sigmoidoscopy or enema, patients will be followed prospectively and monitored for clinical resolution and adverse events at: 3 days (telephone), 3 weeks (clinical assessment), 8 weeks (telephone), 6 months (telephone), and 12 months (telephone) after FMT. Subjects who recur will be offered a second FMT by colonoscopy with a different donor. Microbiome analysis will be conducted from stool samples at baseline and each of the 5 follow-up intervals.
Interventions
- DRUG Fecal Microbiota Preparation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2015-03 |
| Est. Completion | 2018-06 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02403622
The ClinicalTrials.gov registry entry for NCT02403622 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 17 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Microbiome Health Research Institute, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Fecal Microbiota Preparation is the first listed.
NCT02403622 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02403622 about?
NCT02403622 is a clinical study titled "Safety of FMT: OpenBiome Outcomes and Longitudinal Follow-up (STOOL) for Recurrent Clostridium Difficile Infection". The overarching objective of this study is to address the knowledge gap regarding the short-term and long-term safety of fecal microbiota transplants (FMT). The design will be a prospective, open-label, multi-center longitudinal cohort study to assess the short- and long-term safety of FMT as well a...
What is the current status of trial NCT02403622?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 17 participants. The study started on 2015-03. Estimated completion is 2018-06.
What interventions are being tested in trial NCT02403622?
The interventions under investigation include: Fecal Microbiota Preparation (DRUG).
Who is sponsoring clinical trial NCT02403622?
This trial is sponsored by Microbiome Health Research Institute, which has 3 total clinical trials registered on ClinicalTrials.gov.
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