Colonoscopic and oral microbiota transplant therapy yield similar stool and neoterminal ileal engraftment profiles in a single-blind pilot randomized trial.

BACKGROUND: The intestinal microbiota play a key role in Crohn's disease (CD) and postoperative recurrence following ileocecal resection. Microbiota transplant therapy (MTT) could impact postoperative CD recurrence. This study aimed to compare donor engraftment kinetics in the stool and neoterminal ileum in CD participants with a history of ileocecal resection given either liquid MTT administered via colonoscopy or encapsulated, lyophilized, oral MTT.

METHODS: We performed a single-blind (participant), pilot, randomized trial evaluating ileal and stool engraftment kinetics in participants given MTT either via colonoscopy or oral capsules. Participants with a history of ileocecal resection underwent baseline colonoscopy and were randomized (1:1) to a single administration of liquid MTT at the time of colonoscopy or 5 days of MTT capsules. All underwent ileocolonoscopy with biopsies at week 8. Clinical assessments were obtained over 16 weeks.

RESULTS: Alpha and beta diversity were significantly different between baseline neoterminal ileum and stool samples. Stool and mucosal-adherent ileal engraftment levels were not significantly different from each other based on the delivery method at week 8, and stool and ileal engraftments were significantly correlated to each other. Following MTT, there was a significant reduction in CD symptoms measured by the Harvey-Bradshaw Index; however, no differences were noted by the MTT administration route. Donor engraftment did not correlate to clinical outcomes.

CONCLUSIONS: In this pilot study of MTT in postoperative CD, oral and colonoscopy administration had similar donor engraftment. Oral MTT was well tolerated, supporting further evaluation of oral administration earlier in the postoperative disease course.NCT05248191, FMT for Postop Crohn's Disease, https://clinicaltrials.gov/study/NCT05248191.