{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,19]],"date-time":"2026-06-19T16:24:36Z","timestamp":1781886276046,"version":"3.54.5"},"reference-count":35,"publisher":"Frontiers Media SA","license":[{"start":{"date-parts":[[2023,1,12]],"date-time":"2023-01-12T00:00:00Z","timestamp":1673481600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100006498","name":"Clemson University","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100006498","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["frontiersin.org"],"crossmark-restriction":true},"short-container-title":["Front. Med."],"abstract":"<jats:sec><jats:title>Introduction<\/jats:title><jats:p>Growing evidence supports the effectiveness of fecal microbiota transplantation (FMT) in treating ulcerative colitis (UC), although its effects seem to depend on the method of introduction, the number of procedures, the donor material, and the severity of UC.<\/jats:p><\/jats:sec><jats:sec><jats:title>Aim<\/jats:title><jats:p>This study aimed to assess FMT's clinical and microbiological efficacy, tolerability, and safety in patients with mild-to-moderate UC.<\/jats:p><\/jats:sec><jats:sec><jats:title>Material and methods<\/jats:title><jats:p>Patients with mild-to-moderate UC were randomized into two groups. The first group (standard-care, <jats:italic>n<\/jats:italic> = 27) was treated with basic therapy\u2013mesalazine\u2013at a daily dose of 3 g (2 g orally + 1 g rectally). In the second group (FMT group, <jats:italic>n<\/jats:italic> = 26), while taking mesalazine at the indicated dose, each patient with UC as add-on therapy underwent a single FMT procedure with fresh material delivered by colonoscopy from a healthy donor. The clinical efficacy of treatment in both groups was evaluated after 4 and 8 weeks. The primary outcome was remission of UC, defined as a partial Mayo score \u22642, and decreased fecal calprotectin. All patients underwent bacteriological examination of feces for quantitative microbiota composition changes.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Clinical response in the form of a significant decrease in stool frequency and a tendency to normalize its consistency after 4 weeks was detected in 14 (51.9%) patients of the standard care group and 16 patients (61.5%) of the FMT group (<jats:italic>p<\/jats:italic> = 0.583). The Mayo score in the standard care group was 3.59 \u00b1 1.21 and in the FMT group\u22123.15\u00b11.04 (<jats:italic>p<\/jats:italic>=0.166). After 8 weeks, the main primary endpoint was achieved in 70.4% of the standard-care group patients as compared to 84.6% of participants who received FMT as add-on therapy (<jats:italic>p<\/jats:italic> = 0.215). A more pronounced decrease in Mayo score was observed in the FMT group compared to the standard-care group (1.34 \u00b1 1.44 vs. 2.14 \u00b1 1.4; <jats:italic>p<\/jats:italic> = 0.045). All patients also showed a significant decrease in fecal calprotectin levels, which correlated with clinical data, stool frequency, and clinical remission. An improvement in gut microbiota composition was noted in both groups, albeit it was significantly more pronounced in the FMT group.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>FTM in patients with mild-to-moderate UC is a well-tolerated, effective, and safe method of treatment in comparison to basic therapy.<\/jats:p><\/jats:sec><jats:sec><jats:title>Clinical trial registration<\/jats:title><jats:p><jats:ext-link>https:\/\/clinicaltrials.gov\/ct2\/show\/NCT05538026?term=kobyliak&amp;amp;draw=2&amp;amp;rank=4<\/jats:ext-link>, identifier: NCT05538026.<\/jats:p><\/jats:sec>","DOI":"10.3389\/fmed.2022.1049849","type":"journal-article","created":{"date-parts":[[2023,1,12]],"date-time":"2023-01-12T05:17:17Z","timestamp":1673500637000},"update-policy":"https:\/\/doi.org\/10.3389\/crossmark-policy","source":"Crossref","is-referenced-by-count":18,"title":["Efficacy and safety of fecal microbiota transplantation via colonoscopy as add-on therapy in patients with mild-to-moderate ulcerative colitis: A randomized clinical trial"],"prefix":"10.3389","volume":"9","author":[{"given":"Sergii","family":"Tkach","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andrii","family":"Dorofeyev","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Iurii","family":"Kuzenko","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tetyana","family":"Falalyeyeva","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Olena","family":"Tsyryuk","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Oleksandr","family":"Kovalchuk","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nazarii","family":"Kobyliak","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ludovico","family":"Abenavoli","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Luigi","family":"Boccuto","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1965","published-online":{"date-parts":[[2023,1,12]]},"reference":[{"key":"B1","doi-asserted-by":"publisher","first-page":"748","DOI":"10.1053\/j.gastro.2018.12.009","article-title":"AGA clinical practice guidelines on the management of mild-to-moderate ulcerative colitis","volume":"156","author":"Ko","year":"2019","journal-title":"Gastroenterology."},{"key":"B2","doi-asserted-by":"publisher","first-page":"380","DOI":"10.1111\/jgh.14872","article-title":"The epidemiology of inflammatory bowel disease: East meets west","volume":"35","author":"Mak","year":"2020","journal-title":"J Gastroenterol Hepatol."},{"key":"B3","doi-asserted-by":"publisher","first-page":"691","DOI":"10.1111\/apt.16735","article-title":"A nationwide cohort study of the incidence of inflammatory bowel disease in Sweden from 1990 to 2014","volume":"55","author":"Forss","year":"2022","journal-title":"Aliment Pharmacol Ther."},{"key":"B4","doi-asserted-by":"publisher","first-page":"363","DOI":"10.1080\/14712598.2019.1666101","article-title":"Modern use of 5-aminosalicylic acid compounds for ulcerative colitis","volume":"20","author":"Le Berre","year":"2020","journal-title":"Expert Opin Biol Ther."},{"key":"B5","doi-asserted-by":"publisher","first-page":"1756","DOI":"10.1016\/S0140-6736(16)32126-2","article-title":"Ulcerative colitis","volume":"389","author":"Ungaro","year":"2017","journal-title":"Lancet."},{"key":"B6","doi-asserted-by":"publisher","first-page":"147","DOI":"10.1111\/1751-2980.12849","article-title":"Gut microbiota in ulcerative colitis: insights on pathogenesis and treatment","volume":"21","author":"Guo","year":"2020","journal-title":"J Dig Dis."},{"key":"B7","doi-asserted-by":"publisher","first-page":"1","DOI":"10.1007\/s12328-017-0813-5","article-title":"Gut microbiota in the pathogenesis of inflammatory bowel disease","volume":"11","author":"Nishida","year":"2018","journal-title":"Clin J Gastroenterol."},{"key":"B8","doi-asserted-by":"publisher","first-page":"e00065","DOI":"10.14309\/ctg.0000000000000065","article-title":"The gut microbiota in collagenous colitis shares characteristics with inflammatory bowel disease-associated dysbiosis","volume":"10","author":"Carstens","year":"2019","journal-title":"Clin Transl Gastroenterol."},{"key":"B9","doi-asserted-by":"publisher","first-page":"126","DOI":"10.3390\/pathogens8030126","article-title":"Alteration of Gut Microbiota in Inflammatory Bowel Disease (IBD): Cause or Consequence? 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