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

0543954 - ÚŽFG 2022 RIV CH eng J - Článek v odborném periodiku
Březina, J. - Bajer, L. - Wohl, P. - Ďuricová, D. - Hrabák, P. - Novotný, A. - Koželuhová, J. - Lukáš, M. - Mrázek, Jakub - Olša Fliegerová, Kateřina - Kvasnová, Simona - Mekadim, Chahrazed - 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. Roč. 10, č. 13 (2021), č. článku 2753. E-ISSN 2077-0383
Grant CEP: GA MZd(CZ) NV16-27449A
Institucionální podpora: RVO:67985904
Klíčová slova: ulcerative colitis * fecal microbial transplantation * 5-aminosalicylic acid
Obor OECD: Microbiology
Impakt faktor: 4.964, rok: 2021
Způsob publikování: Open access
https://www.mdpi.com/2077-0383/10/13/2753

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.
Trvalý link: http://hdl.handle.net/11104/0321043