Capsule Delivery of Fecal Microbiota Transplant is Well Tolerated in Ulcerative Colitis Patients

Introduction: Fecal microbiota transplant (FMT) is increasingly being explored as a potential therapy for ulcerative colitis (UC). Optimal frequency, duration, and mode of delivery have not yet been defined. Studies of FMT in UC using repeated therapy via enema demonstrated good results although this mode of delivery may be burdensome for long term therapy. Recent data in recurrent clostridium difficile infection (rCDI) indicate that FMT delivered by capsule (cap-FMT) may be equally efficacious to delivery by colonoscopy. However, cap-FMT has not yet been studied for management of UC. We aimed to investigate the tolerability of cap-FMT in UC patients as a maintenance regimen following FMT via colonoscopic infusion. Methods: We performed an open-label, prospective trial of FMT in patients with endoscopically and histologically confirmed UC. As an optional extension arm, patients were given a maintenance regimen of 10 FMT capsules once a week for 6 weeks. All participants received FMT by colonoscopy on two separate occasions, 1 month apart, prior to entering this arm of the study. Concomitant therapies were allowed to continue. The primary outcome was a composite safety endpoint (NIH grade ≥ 2 adverse event or escalation of therapy). Secondary outcome was decrease in modified Mayo score. Results: 15 patients enrolled to receive cap-FMT. Two patients were excluded due to lack of follow-up data. Of the 13 patients who completed follow-up, 3 experienced minor adverse events including diarrhea and constipation, resulting in 2 patients discontinuing cap-FMT (one after 3 weeks of cap-FMT; one after 4 weeks of cap-FMT). No patients experienced serious adverse events or required escalation of UC therapy. There was no significant improvement in mean Modified Mayo Score from initiation of capsule-FMT and at completion of the 6 weeks in the 11 patients who did complete the course (2.82 vs. 2.18, p=0.35). Conclusion: While cap-FMT has been reported in UC patients for treatment of rCDI, this is the first report of cap-FMT for treatment of UC. Cap-FMT was overall well tolerated in our study with no serious adverse events in our cohort. Modified Mayo score did not significantly decrease after initiation of cap-FMT possibly because the group who entered the extension arm of capsule therapy already had well controlled disease following colonoscopic administration of FMT. Future studies should focus on comparing efficacy of enema delivery to cap-FMT considering patient convenience.625 Figure 1 No Caption available.