Use of Fidaxomicin Compared to Vancomycin for Decolonization of C. Difficile in Patients With Inflammatory Bowel Disease
Key facts
- Where
- Boston, United StatesSee the site
- Phase
- Phase 4
Where in United States
- Brigham and Women's HospitalBoston, United StatesNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Brigham and Women's Hospital
- Trial code
- NCT06794944
- Record updated
- 3 November 2025
- Original description
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.Read full original descriptionShow less
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.
Inclusion: Signed informed consent; Male or female > 18 years of age; IBD diagnosis (CD, UC or indeterminant Colitis will be permitted.); Presenting for outpatient colonoscopy for any indication.
Exclusion: Patients with previous colectomy, ostomy, J-pouch, or previous colon surgery (excluding appendectomy.); Allergy or sensitivity to vancomycin, fidaxomicin, or microcrystalline cellulose; Unable to provide consent; Unable to complete study procedures; Chronic use of antibiotics; Inability or unwillingness to swallow capsules.