O9\u2005STOP-colitis pilot: prospective, open-label, randomised study comparing nasogastric versus colonic FMT delivery in ulcerative colitis

Abstract

Introduction Although faecal microbiota transplantation (FMT) appears to hold therapeutic potential for ulcerative colitis (UC), the optimal administration route and dose of FMT is unknown. This pilot trial aimed to identify the optimal route of administration to further test in an RCT. Methods In this prospective, three-centre, open-label, randomised study (STOP-Colitis pilot), we compared delivery of FMT via the naso-gastric (NG) or colonic (COLON) route in adult patients with active UC. Participants were administered 8 infusions of FMT over an 8 week period. Clinical response was defined as ≥3 point and ≥30% reduction in Mayo score at week 8 compared to baseline. Clinical remission was defined as Mayo score of ≤2, with no subscore >1 at week 8. The primary outcome was based on clinical response and safety at weeks 8 and 12, along with qualitative assessment of acceptability. Results 30 participants were randomised between March 2018 and April 2019; 16 to NG; 14 to COLON. 8 in NG arm and 2 patients in the COLON arm withdrew from the study before completion. Clinical response was achieved in more participants who received FMT via COLON compared with NG (9/12 [75%] vs 2/8 [25%]; adjusted relative risk [RR] 2.94 [95% CI, 0.84, 10.30]). Clinical remission was observed in more participants undergoing FMT via COLON compared to NG (6/12 [50%] vs 2/8 [25%] respectively; RR 1.89 [95% CI, 0.51, 6.99]). IBDQ and SF-36 scores at week 8 and 12 were similar in NG and COLON groups. Qualitative analysis showed greater patient and clinician acceptability for colonic delivery. There were three serious adverse events (one considered a serious adverse event) in 2 participants in the NG arm, and none in the COLON arm. Conclusion This pilot study suggests that in patients with active UC, FMT delivered via the COLON route appears to be safe and better tolerated with signals suggesting greater efficacy compared to the NG route. A randomised, double-blind, placebo-controlled trial of colonic delivery of FMT is now underway to determine clinical efficacy and safety.