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

Launched by BRIGHAM AND WOMEN'S HOSPITAL · Jan 21, 2025

Keywords

ClinConnect Summary

This clinical trial is studying two antibiotics, fidaxomicin and vancomycin, to see which one works better for treating a type of infection called C. difficile in patients with inflammatory bowel disease (IBD). The trial will include 60 patients who are over 18 years old and have been diagnosed with IBD. To participate, patients must be scheduled for an outpatient colonoscopy and able to provide consent. However, those with certain medical conditions, such as previous bowel surgeries or chronic antibiotic use, will not be eligible.

Participants in the trial will be randomly assigned to receive either fidaxomicin or vancomycin for 10 days, both in capsule form. To ensure that neither the patients nor the researchers know which medication they are receiving (a process called "blinding"), the capsules will look the same. Throughout the study, participants will have their gut health monitored through microbiome assessments and C. difficile testing at various time points. This trial is not yet recruiting, but it aims to provide important information about the best treatment options for patients with IBD who also have C. difficile infections.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Signed informed consent.
• • 2. Male or female \> 18 years of age.
• • 3. IBD diagnosis (CD, UC or indeterminant Colitis will be permitted.)
• • 4. Presenting for outpatient colonoscopy for any indication.
• Exclusion Criteria:
• • 1. Unable to provide consent.
• • 2. Patients with previous colectomy, ostomy, J-pouch, or previous colon surgery (excluding appendectomy.)
• • 3. Unable to complete study procedures.
• • 4. Chronic use of antibiotics.
• • 5. Inability or unwillingness to swallow capsules.
• • 6. Allergy or sensitivity to vancomycin, fidaxomicin, or microcrystalline cellulose.