ICON-2: FMT and Bezlotoxumab Compared to FMT and Placebo for Patients With IBD and CDI
Status:
Recruiting
Trial end date:
2023-12-30
Target enrollment:
Participant gender:
Summary
This is a randomized controlled trial to assess the clinical and microbiological impacts of
FMT in combination with Bezlotoxumab (bezlo) compared to FMT in combination with placebo in
patients with both inflammatory bowel disease (IBD) a and clostridium difficile infection
(CDI). The investigators will prospectively enroll up to 150 IBD-CDI patients from 4 tertiary
care FMT referral centers. Patients will be randomized 1:1 to either receive FMT in
combination with Bezlo of FMT and a placebo infusion. Donor stool from healthy donors will be
obtained from OpenBiome. OpenBiome is a nonprofit 501(c)(3) organization that provides
hospitals with screened, filtered, and frozen material ready for clinical use. Patients will
be enrolled and followed prospectively for 3 months post therapy. Stool and blood samples as
well as clinical data will be collected at baseline, week 1, 8 and 12.