FECAL MICROBIOTA TRANSPLANT FOR C. DIFFICILE INFECTION IN SOLID ORGAN TRANSPLANT RECIPIENTS

AbstractClostridium difficile is the most frequent bacterial cause of antibiotic-associated diarrhea. Solidorgan transplant recipients have a higher rate of C. difficile infection (CDI), and greater risk foradverse consequences because of immunosuppression, frequent antibiotic use and medicalprocedures all of which disrupt the normal gut microbiota. Dysbiosis of the gut microbiotapredisposes to CDI which, despite treatment can recur in 30% of patients. A novel way toprevent CDI recurrence is by instilling feces from a healthy individual into the intestine of theCDI patient, thereby restoring balance in the gut microbiota. However, it is unknown whether ornot fecal microbiota transplantation (FMT) is an efficacious choice for CDI recurrence preventionin SOT recipients. We propose a randomized, double-blind double-dummy placebo-controlledtrial at five sites comparing FMT with oral vancomycin for 158 SOT recipients with at least a firstbut no more than 3 recurrences of CDI. We will collect fecal and blood samples from subjectsprior to and after FMT and collect data on recurrence, CDI-related quality of life, microbiotacomposition and function. The trial's primary endpoint is recurrent CDI in the 60-day time framefollowing completion of treatment. Secondary outcomes are safety and gut microbiotacharacteristics. Each subject will contribute 6 stool samples, 3 blood samples and will have 6clinic visits. Total duration of follow-up will be 24 weeks per subject. The FMT will beadministered via enema using frozen stool from universal donors. By following patients for 6months, we will determine whether FMT successfully and safely reduces recurrence of CDI andimproves other outcomes in SOT recipients with CDI.