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.
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.
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.
Parallel
Vancomycin (POC)
DrugVancomycin is glycopeptide antibiotic that has broad gram-positive coverage. Patients will receive 125mg PO every 6 hours for 10 days.
Fidaxomicin
DrugFidaxomicin is a macrolide antibiotic. It is narrow spectrum with potent bactericidal activity specifically against C. difficile. Patients will receive 200mg PO twice daily for 10 days.
C. difficile decolonization
Absence of C. difficile via PCR in Week 8 stool sample
Safety and tolerability
Subject incidence of treatment-emergent adverse events (including treatment-emergent adverse events for clinically significant changes in laboratory parameters and vital signs)
Biomass of C. difficile
Change in stool C. difficile biomass in patients at week 8 by quantitative culture and qPCR
Long-term effect of C. difficile decolonization on IBD clinical outcomes
Change in IBD clinical scores from baseline at week 8 and week 26. IBD clinical scores are used to assess IBD patient symptoms. The assessments are separated between scores for Ulcerative Colitis (UC) and Crohn's Disease (CD). The Harvey Bradshaw Index (HBI) is a clinical assessment for IBD patients with Crohn's disease while Partial Mayo Score is a clinical assessment for Ulcerative Colitis. The scores will be collected at study visit in form of a survey. The HBI score can vary but a score above 8 or 9 is considered severe disease activity. The Partial Mayo Score can range from 0 to 9 and a score above 7 is considered severe disease activity. A decrease in score from baseline to follow-up timepoints is indicative of improved IBD patient symptoms. A decrease in score from baseline to follow-up timepoints is indicative of improved IBD patient symptoms.
C. difficile infection surveillance
Incidence of patients developing CDI through Week 26
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