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NCT03829475 · ClinicalTrials.gov registry record · Phase 2
ICON-2: FMT and Bezlotoxumab Compared to FMT and Placebo for Patients With IBD and CDI
A Phase 2 study, sponsored by Brigham and Women's Hospital.
- Completed
- Registry status
- Phase 2
- Development phase
- 61
- Enrollment target
NCT03829475 is a Phase 2 study that has completed, run by Brigham and Women's Hospital. The registered enrollment target is 61 participants.
The verdict
NCT03829475, a Phase 2 study, has completed, sponsored by Brigham and Women's Hospital.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 61 participants
- Enrollment target
Study Summary
This is a randomized controlled trial to assess the clinical and microbiological impacts of FMT in combination with Bezlotoxumab (bezlo) compared to FMT in combination with placebo in patients with both inflammatory bowel disease (IBD) a and clostridium difficile infection (CDI). The investigators will prospectively enroll up to 150 IBD-CDI patients from 4 tertiary care FMT referral centers. Patients will be randomized 1:1 to either receive FMT in combination with Bezlo of FMT and a placebo infusion. Donor stool from healthy donors will be obtained from OpenBiome. OpenBiome is a nonprofit 501(c)(3) organization that provides hospitals with screened, filtered, and frozen material ready for clinical use. Patients will be enrolled and followed prospectively for 3 months post therapy. Stool and blood samples as well as clinical data will be collected at baseline, week 1, 8 and 12.
Interventions
- DRUG Placebo
- DRUG Fecal Microbiota Transplantation
- DRUG Bezlotoxumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 61 participants |
| Start Date | 2020-01-01 |
| Est. Completion | 2025-06-01 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03829475
The ClinicalTrials.gov registry entry for NCT03829475 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 61 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Brigham and Women's Hospital, which has 937 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT03829475 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03829475 about?
NCT03829475 is a clinical study titled "ICON-2: FMT and Bezlotoxumab Compared to FMT and Placebo for Patients With IBD and CDI". This is a randomized controlled trial to assess the clinical and microbiological impacts of FMT in combination with Bezlotoxumab (bezlo) compared to FMT in combination with placebo in patients with both inflammatory bowel disease (IBD) a and clostridium difficile infection (CDI). The investigators w...
What is the current status of trial NCT03829475?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 61 participants. The study started on 2020-01-01. Estimated completion is 2025-06-01.
What interventions are being tested in trial NCT03829475?
The interventions under investigation include: Placebo (DRUG), Fecal Microbiota Transplantation (DRUG), Bezlotoxumab (DRUG).
Who is sponsoring clinical trial NCT03829475?
This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.
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