Fecal Microbial Transplant in Pediatric Crohn's Disease: A Double Blind Placebo Control Study

Thirty-two patients with mild to moderate active Crohn's Disease (PCDAI 15-45) aged 12-21 will be enrolled in this study. Patients will be randomized into pre-treatment conditioning + FMT versus pre-treatment conditioning + placebo.

Pre transplant conditioning will include rifaximin (400mg PO three times a day x 10 days prior to transplant), MiraLAX cleanout (2 days prior to cleanout), and omeprazole (day prior and day of transplant). Study subjects will have a nasogastric (NG) tube placed on the day of the transplant after which either donor stool or normal saline (placebo) will be infused via the tube. A designated clinician will do the transplants and keep the subject blinded to the treatment group. A different designated clinician, blinded to the treatment group of the subject, will do the follow-up telephone calls and visits.

Study subjects will have telephone follow up 2 days and at 2, 6 and 12 weeks post transplant they will be seen in clinic. The PCDAI will be completed at all the study visits (excluding the phone call). Additionally, the physcian's global assessment will be documented at each study visit (excluding the phone call). The global assessment will be reported as quiescent, mild, moderate or severe.

Study subject recipients/guardian will be provided diary cards from initiation of rifaximin to 12 weeks post transplant to record AEs, and these will be reviewed at every follow-up encounter. The diary card will include duration of event, intensity of event, and medications or actions taken for the event.

Individuals who received placebo treatment will be offered FMT at termination of study. These patients will then be followed at week 2, 6 and 12 post transplant in the CRC. Donor stool will be saved in the Clinical Research Lab at the initial baseline visit. This stool will be used for the FMT for these individuals.