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

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-...

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Autores principales: Březina, Jan, Bajer, Lukáš, Wohl, Pavel, Ďuricová, Dana, Hrabák, Pavel, Novotný, Aleš, Koželuhová, Jana, Lukáš, Milan, Mrázek, Jakub, Fliegerová, Kateřina Olša, Kvasnová, Simona, Chahrazed, Mekadim, Mareš, Jan, Špičák, Julius, Drastich, Pavel
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8268406/
https://www.ncbi.nlm.nih.gov/pubmed/34206663
http://dx.doi.org/10.3390/jcm10132753
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author Březina, Jan
Bajer, Lukáš
Wohl, Pavel
Ďuricová, Dana
Hrabák, Pavel
Novotný, Aleš
Koželuhová, Jana
Lukáš, Milan
Mrázek, Jakub
Fliegerová, Kateřina Olša
Kvasnová, Simona
Chahrazed, Mekadim
Mareš, Jan
Špičák, Julius
Drastich, Pavel
author_facet Březina, Jan
Bajer, Lukáš
Wohl, Pavel
Ďuricová, Dana
Hrabák, Pavel
Novotný, Aleš
Koželuhová, Jana
Lukáš, Milan
Mrázek, Jakub
Fliegerová, Kateřina Olša
Kvasnová, Simona
Chahrazed, Mekadim
Mareš, Jan
Špičák, Julius
Drastich, Pavel
author_sort Březina, Jan
collection PubMed
description 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.
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spelling pubmed-82684062021-07-10 Fecal Microbial Transplantation versus Mesalamine Enema for Treatment of Active Left-Sided Ulcerative Colitis—Results of a Randomized Controlled Trial Březina, Jan Bajer, Lukáš Wohl, Pavel Ďuricová, Dana Hrabák, Pavel Novotný, Aleš Koželuhová, Jana Lukáš, Milan Mrázek, Jakub Fliegerová, Kateřina Olša Kvasnová, Simona Chahrazed, Mekadim Mareš, Jan Špičák, Julius Drastich, Pavel J Clin Med Article 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. MDPI 2021-06-22 /pmc/articles/PMC8268406/ /pubmed/34206663 http://dx.doi.org/10.3390/jcm10132753 Text en © 2021 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Březina, Jan
Bajer, Lukáš
Wohl, Pavel
Ďuricová, Dana
Hrabák, Pavel
Novotný, Aleš
Koželuhová, Jana
Lukáš, Milan
Mrázek, Jakub
Fliegerová, Kateřina Olša
Kvasnová, Simona
Chahrazed, Mekadim
Mareš, Jan
Špičák, Julius
Drastich, Pavel
Fecal Microbial Transplantation versus Mesalamine Enema for Treatment of Active Left-Sided Ulcerative Colitis—Results of a Randomized Controlled Trial
title Fecal Microbial Transplantation versus Mesalamine Enema for Treatment of Active Left-Sided Ulcerative Colitis—Results of a Randomized Controlled Trial
title_full Fecal Microbial Transplantation versus Mesalamine Enema for Treatment of Active Left-Sided Ulcerative Colitis—Results of a Randomized Controlled Trial
title_fullStr Fecal Microbial Transplantation versus Mesalamine Enema for Treatment of Active Left-Sided Ulcerative Colitis—Results of a Randomized Controlled Trial
title_full_unstemmed Fecal Microbial Transplantation versus Mesalamine Enema for Treatment of Active Left-Sided Ulcerative Colitis—Results of a Randomized Controlled Trial
title_short Fecal Microbial Transplantation versus Mesalamine Enema for Treatment of Active Left-Sided Ulcerative Colitis—Results of a Randomized Controlled Trial
title_sort fecal microbial transplantation versus mesalamine enema for treatment of active left-sided ulcerative colitis—results of a randomized controlled trial
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8268406/
https://www.ncbi.nlm.nih.gov/pubmed/34206663
http://dx.doi.org/10.3390/jcm10132753
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