NCT06794944Not yet recruitingPhase 4
Use of Fidaxomicin Compared to Vancomycin for Decolonization of C. Difficile in Patients With Inflammatory Bowel Disease
Source: ClinicalTrials.gov · Last updated 3 Nov 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 21 Jan 2025
- Start date
- Sept 2026
- Primary completion date
- 1 Sept 2030
- Lead sponsor
- Brigham and Women's Hospital
- Diseases
- Crohn's disease, Ulcerative colitis
- NCT number
- NCT06794944
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 60
- From Sept 2026 to the primary completion date, 1 Sept 2030
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with previous colectomy, ostomy, J-pouch, or previous colon surgery (excluding appendectomy.)
Other illness
- Allergy or sensitivity to vancomycin, fidaxomicin, or microcrystalline cellulose.
Other
- Unable to provide consent.
- Unable to complete study procedures.
- Chronic use of antibiotics.
- Inability or unwillingness to swallow capsules.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Brigham and Women's Hospital Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.