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

Brief description of study

This study will find out if fecal microbiota transplantation (also known as FMT) paired with Bezlotoxumab compared to FMT and placebo is a better treatment for Clostridium difficile infection (CDI) in people with inflammatory bowel disease (IBD). FMT is the transfer of bacteria from a healthy donor’s colon to a recipient’s colon during a colonoscopy. FMT is used to treat recurrent Clostridium difficile infections. Bezlotoxumab is an antibody that binds to Clostridium difficile toxin B and is used to prevent recurrence of CDI in adults at risk. This research study will compare FMT and Bezlotoxumab to FMT and placebo. The placebo looks exactly like Bezlotoxumab, but contains no Bezlotoxumab. During this study, participants may get a placebo instead of Bezlotoxumab. Placebos are used in research studies to see if the results are due to the study drug or due to other reasons

Clinical Study Identifier: s21-00544
ClinicalTrials.gov Identifier: NCT03829475

If you are registered as a volunteer, please log in to contact the study team/express interest in this study.