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

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorBrigham and Women's Hospital

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

Unable to provide consent.

Patients with previous colectomy, ostomy, J-pouch, or previous colon surgery (excluding appendectomy.)

Unable to complete study procedures.

Chronic use of antibiotics.

Trial design

Treatments tested in this trial

  • Vancomycin (POC)
  • Fidaxomicin

Treatment groups

60 Participants
are divided into 2 treatment groups

Sponsors and collaborators