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NCT03795233 · ClinicalTrials.gov registry record · Phase 1
Fecal Microbiota Transplant for Primary CDI
A Phase 1 study, sponsored by Boston Medical Center.
- Terminated
- Registry status
- Phase 1
- Development phase
- 5
- Enrollment target
NCT03795233 is a Phase 1 study that was terminated before completion, run by Boston Medical Center. The registered enrollment target is 5 participants.
The verdict
NCT03795233, a Phase 1 study, was terminated before completion, sponsored by Boston Medical Center.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 5 participants
- Enrollment target
Study Summary
Clostridium difficile infection (CDI) is one of the most urgent health threats in the U.S. associated with antibiotic use. After an initial episode, disease recurrence is high and relapses can occur in 20-30% of people treated with oral vancomycin. An antibiotic course can affect the gut microbiome for years, and patients with CDI have additional dysbiosis of their gut flora. Oral vancomycin perturbs the gut microbiome further. Restoration of the microbiome with Fecal Microbiota Transplant (FMT) has been proven a highly efficacious and cost-effective treatment for recurrent CDI. FMT has had very limited study for a primary episode of CDI to date because an endoscopic procedure was the recommended route of delivery. However, FMT is now available via frozen oral capsules and has been shown to be non-inferior to FMT via colonoscopy in randomized controlled trials. The investigators hypothesize that outcomes after a first episode of CDI can be improved if the microbiome is restored with oral FMT. It is further hypothesized that this will compensate for any additional microbiome perturbation caused by administration of oral vancomycin and decrease the likelihood of recurrence. Because the hypothesis is based on restoration of the microbiome, the investigators propose this proof-of-concept pilot study to examine whether FMT administered after oral vancomycin therapy for primary CDI restores microbiome diversity compared to patients who do not receive FMT. Because of the potential health benefits, this approach deserves further study. The results from this pilot study on the microbiome diversity as well as the surveys to be conducted about GI symptomatology (e.g., diarrhea, abdominal pain, bloating), CDI recurrence and healthcare utilization, would provide preliminary data to support a randomized controlled, multicenter clinical trial.
Interventions
- BIOLOGICAL Fecal microbiota transplant G3 capsules
- OTHER Oral Vancomycin alone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2019-08-23 |
| Est. Completion | 2021-01-15 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03795233
The ClinicalTrials.gov registry entry for NCT03795233 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 5 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boston Medical Center, which has 253 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Fecal microbiota transplant G3 capsules is the first listed.
NCT03795233 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03795233 about?
NCT03795233 is a clinical study titled "Fecal Microbiota Transplant for Primary CDI". Clostridium difficile infection (CDI) is one of the most urgent health threats in the U.S. associated with antibiotic use. After an initial episode, disease recurrence is high and relapses can occur in 20-30% of people treated with oral vancomycin. An antibiotic course can affect the gut microbiome ...
What is the current status of trial NCT03795233?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 5 participants. The study started on 2019-08-23. Estimated completion is 2021-01-15.
What interventions are being tested in trial NCT03795233?
The interventions under investigation include: Fecal microbiota transplant G3 capsules (BIOLOGICAL), Oral Vancomycin alone (OTHER).
Who is sponsoring clinical trial NCT03795233?
This trial is sponsored by Boston Medical Center, which has 253 total clinical trials registered on ClinicalTrials.gov.
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