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Use of Fidaxomicin Compared to Vancomycin for Decolonization of C. Difficile in Patients With Inflammatory Bowel Disease

StatusNot Yet Recruiting
PhasePhase 4
Started2026-09
View on ClinicalTrials.gov ↗

Amendment history

2025-10-31
minor
Study Identification, Study Status, Outcome Measures v2
Start date2025-09→2026-09
Secondary endpointsdetails revised at 1 of 3 entries
Study titlerevised
Use of Fidaxomicin Compared to Vancomycin for Decolonization of C. Difficile in Patients withWith Inflammatory Bowel Disease
2025-02-03
minor
Study Status, Outcome Measures v1
Secondary endpointsdetails revised at 1 of 3 entries
2025-01-21
minor
Original filing
This is a randomized, double-blind study to assess the safety and efficacy of fidaxomicin compared to vancomycin for decolonization of C. difficile in IBD patients. A total of 60 patients who meet eligibility criteria will be randomized 1:1 to either the fidaxomicin or vancomycin arm. The vancomycin arm will receive a dose of 125 mg PO q 6 hours for 10 days. The fidaxomicin arm will receive 200 mg PO BID for 10 days. In order to ensure blinding, both antibiotics will be concealed in opaque 00 capsule shells. In addition, those in the fidaxomicin arm will receive 2 placebo capsules so that all participants will receive 4 capsules daily for 10 days. Microbiome assessment and C. difficile testing will be performed at baseline, day 5, day 10, and weeks 4, 8, and 26.
Trial Details
NCT Number NCT06794944
Lead Sponsor Brigham and Women's Hospital
Conditions Inflammatory Bowel Disease (IBD), Clostridioides Difficile Infection
Enrollment 60 participants
Start Date 2026-09
Primary Completion 2030-09-01 (estimated)
Study Completion 2031-09 (estimated)
Updated on ClinicalTrials.gov 2025-11-03