Abstract
Background and Aims: Ulcerative colitis (UC) is a chronic inflammatory disease. Fecal microbial transplantation (FMT) is a promising alternative treatment. Methods: This multicenter, open-label, noninferiority trial randomized patients with active left-sided UC (Mayo score 4–10) equally to FMT or 5-aminosalicylic acid (5-ASA) enemas. FMT enemas were administered five times in the first week and then once weekly for 5 weeks. 5-ASA enemas were administered daily for 2 weeks and then every other day. The primary study endpoint was clinical remission, with a total Mayo score ≤2 at week 12 with no subscore >1. Results: Sixty-one patients were screened; 45 were enrolled and randomized to FMT (n = 23) or 5-ASA (n = 22). Twenty-one FMT and 22 5-ASA patients completed at least the week 4 study visit and were included in the mITT analysis. Twelve FMT (57%) and eight 5-ASA patients achieved the primary study endpoint. FMT noninferiority with 10% margin was confirmed (95% CI: −7.6%, 48.9%). Adverse events occurred in 12 FMT (57%) and 13 5-ASA (59%) patients. Increased microbial diversity persisted 3 months after FMT. Conclusion: FMT is an effective treatment for left-sided UC and increased recipient microbiome diversity. Targeted microbiome modification may improve FMT efficacy. Further investigation is needed to guide donor and patient selection.
Highlights
Ulcerative colitis (UC) is a chronic inflammatory disease of the colonic mucosa and submucosa
As Fecal microbial transplantation (FMT) administered as an enema can be seen as a topical therapy, we decided to compare its efficacy and safety with that of mesalamine in the noninferiority FACTU trial, the first randomized controlled trial (RCT) to compare FMT enema with topical 5-aminosalicylic acid (5-ASA) therapy in patients with left-sided UC
This study assessed the clinical efficacy of FMT enema in patients with left-sided UC with mild to moderate disease activity
Summary
Ulcerative colitis (UC) is a chronic inflammatory disease of the colonic mucosa and submucosa. None of the studies evaluated patients with left-sided UC, which accounts for 30–50% of the cases [12] Even though their clinical course and therapy may differ, left-sided colitis is perceived as the same disease as pancolitis [12]. As FMT administered as an enema can be seen as a topical therapy, we decided to compare its efficacy and safety with that of mesalamine in the noninferiority FACTU (fecal bacteriotherapy for ulcerative colitis) trial, the first randomized controlled trial (RCT) to compare FMT enema with topical 5-aminosalicylic acid (5-ASA) therapy in patients with left-sided UC. Methods: This multicenter, open-label, noninferiority trial randomized patients with active left-sided UC (Mayo score 4–10) to FMT or 5-aminosalicylic acid (5-ASA) enemas. Conclusion: FMT is an effective treatment for left-sided UC and increased recipient microbiome diversity. Further investigation is needed to guide donor and patient selection
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
