O9 STOP-colitis pilot: prospective, open-label, randomised study comparing nasogastric versus colonic FMT delivery in ulcerative colitis
نویسندگان
چکیده
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 identify further test in an RCT. Methods In this prospective, three-centre, open-label, randomised study (STOP-Colitis pilot), we compared delivery via naso-gastric (NG) or colonic (COLON) adult patients with active UC. Participants were administered 8 infusions over week period. Clinical response was defined as ≥3 point ≥30% reduction Mayo score at baseline. remission ≤2, no subscore >1 8. The primary outcome based on clinical safety weeks 12, along qualitative assessment acceptability. Results 30 participants between March 2018 April 2019; 16 NG; 14 COLON. NG arm 2 COLON withdrew from before completion. achieved more who received (9/12 [75%] vs 2/8 [25%]; adjusted relative risk [RR] 2.94 [95% CI, 0.84, 10.30]). observed undergoing (6/12 [50%] [25%] respectively; RR 1.89 0.51, 6.99]). IBDQ SF-36 scores 12 similar groups. Qualitative analysis showed greater patient clinician acceptability delivery. There three serious adverse events (one considered a event) arm, none arm. Conclusion suggests that UC, delivered be safe better tolerated signals suggesting efficacy route. A randomised, double-blind, placebo-controlled now underway determine safety.
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ژورنال
عنوان ژورنال: Oral
سال: 2021
ISSN: ['2673-6373']
DOI: https://doi.org/10.1136/gutjnl-2020-bsgcampus.9