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Fecal Microbial Transplantation versus Mesalamine Enema for Treatment of Active Left-Sided Ulcerative Colitis—Results of a Randomized Controlled Trial

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Hepatogastroenterology Department, Institute for Clinical and Experimental Medicine, 14021 Prague, Czech Republic
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Clinical and Research Centre for IBD ISCARE, 19000 Prague, Czech Republic
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4th Department of Medicine—Department of Gastroenterology and Hepatology, First Faculty of Medicine, Charles University and General University Hospital in Prague, 12808 Prague, Czech Republic
4
Gastroenterology Department, I. Internal Clinic, University Hospital in Pilsen, 30100 Pilsen, Czech Republic
5
Institute of Animal Physiology and Genetics of the Czech Academy of Science, v.v.i., 14220 Prague, Czech Republic
*
Author to whom correspondence should be addressed.
Academic Editors: Angelo Viscido and Andrew Day
J. Clin. Med. 2021, 10(13), 2753; https://doi.org/10.3390/jcm10132753
Received: 15 May 2021 / Revised: 16 June 2021 / Accepted: 16 June 2021 / Published: 22 June 2021
(This article belongs to the Section Gastroenterology & Hepatopancreatobiliary Medicine)
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. View Full-Text
Keywords: ulcerative colitis; fecal microbial transplantation; 5-aminosalicylic acid ulcerative colitis; fecal microbial transplantation; 5-aminosalicylic acid
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MDPI and ACS Style

Březina, J.; Bajer, L.; Wohl, P.; Ďuricová, D.; Hrabák, P.; Novotný, A.; Koželuhová, J.; Lukáš, M.; Mrázek, J.; Fliegerová, K.O.; Kvasnová, S.; Chahrazed, M.; Mareš, J.; Špičák, J.; Drastich, P. Fecal Microbial Transplantation versus Mesalamine Enema for Treatment of Active Left-Sided Ulcerative Colitis—Results of a Randomized Controlled Trial. J. Clin. Med. 2021, 10, 2753. https://doi.org/10.3390/jcm10132753

AMA Style

Březina J, Bajer L, Wohl P, Ďuricová D, Hrabák P, Novotný A, Koželuhová J, Lukáš M, Mrázek J, Fliegerová KO, Kvasnová S, Chahrazed M, Mareš J, Špičák J, Drastich P. Fecal Microbial Transplantation versus Mesalamine Enema for Treatment of Active Left-Sided Ulcerative Colitis—Results of a Randomized Controlled Trial. Journal of Clinical Medicine. 2021; 10(13):2753. https://doi.org/10.3390/jcm10132753

Chicago/Turabian Style

Březina, Jan, Lukáš Bajer, Pavel Wohl, Dana Ďuricová, Pavel Hrabák, Aleš Novotný, Jana Koželuhová, Milan Lukáš, Jakub Mrázek, Kateřina O. Fliegerová, Simona Kvasnová, Mekadim Chahrazed, Jan Mareš, Julius Špičák, and Pavel Drastich. 2021. "Fecal Microbial Transplantation versus Mesalamine Enema for Treatment of Active Left-Sided Ulcerative Colitis—Results of a Randomized Controlled Trial" Journal of Clinical Medicine 10, no. 13: 2753. https://doi.org/10.3390/jcm10132753

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