NCT03829475View on ClinicalTrials.gov

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

PHASE2Active, not recruitingINTERVENTIONAL

Enrollment

Participants

Timeline

Start Date

January 1, 2020

Primary Completion Date

August 3, 2023

Study Completion Date

June 1, 2025

Conditions

Inflammatory Bowel DiseasesClostridium Difficile Infection

Interventions

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

Trial Locations (1)

02115

Brigham and Women's Hospital, Boston

All Listed Sponsors

lead

Brigham and Women's Hospital

OTHER

NCT03829475 - ICON-2: FMT and Bezlotoxumab Compared to FMT and Placebo for Patients With IBD and CDI | Biotech Hunter | Biotech Hunter