NCT03829475

ICON-2: FMT and Bezlotoxumab Compared to FMT and Placebo for Patients With IBD and CDI

A Randomized Controlled Trial to Compare the Effectiveness of Fecal Microbiota Transplantation (FMT) in Combination With Bezlotoxumab Compared to FMT and Placebo for the Prevention of CDI Recurrence in Patients With Inflammatory Bowel Disease and Recurrent Clostridium Difficile Infection

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: Brigham and Women's Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Inflammatory Bowel Diseases
• Clostridium Difficile Infection

Interventions

Type	Name	Description
DRUG	Bezlotoxumab	This is a a fully human monoclonal antibody that binds to C. difficile toxin B, and is indicated to prevent recurrence of CDI in adults at risk for recurrent CDI (rCDI).
DRUG	Placebo	placebo is an infusion of normal saline.
DRUG	Fecal Microbiota Transplantation	FMT is an infusion of prescreened donor stool that will be administered via colonoscopy

Timeline

• Start date: 2020-01-01
• Primary completion: 2023-08-03
• Completion: 2025-06-01
• First posted: 2019-02-04
• Last updated: 2025-12-09
• Results posted: 2024-12-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study