{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,27]],"date-time":"2026-10-27T22:09:48Z","timestamp":1793138988263,"version":"4.5.0"},"reference-count":37,"publisher":"Ovid Technologies (Wolters Kluwer Health)","issue":"5","license":[{"start":{"date-parts":[[2021,3,16]],"date-time":"2021-03-16T00:00:00Z","timestamp":1615852800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"},{"start":{"date-parts":[[2021,3,16]],"date-time":"2021-03-16T00:00:00Z","timestamp":1615852800000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["lww.com","ovid.com"],"crossmark-restriction":true},"short-container-title":["Hepatology"],"published-print":{"date-parts":[[2021,5]]},"abstract":"<jats:sec>\n            <jats:title>Background and Aims<\/jats:title>\n            <jats:p>Alcohol use disorder (AUD) is associated with microbial alterations that worsen with cirrhosis. Fecal microbiota transplant (FMT) could be a promising approach.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Approach and Results<\/jats:title>\n            <jats:p>In this phase 1, double\u2010blind, randomized clinical trial, patients with AUD\u2010related cirrhosis with problem drinking (AUDIT\u201010\u00a0&gt;\u00a08) were randomized 1:1 into receiving one placebo or FMT enema from a donor enriched in <jats:italic toggle=\"yes\">Lachnospiraceae<\/jats:italic> and <jats:italic toggle=\"yes\">Ruminococcaceae<\/jats:italic>. Six\u2010month safety was the primary outcome. Alcohol craving questionnaire, alcohol consumption (urinary ethylglucuronide\/creatinine), quality of life, cognition, serum IL\u20106 and lipopolysaccharide\u2010binding protein, plasma\/stool short\u2010chain fatty acids (SCFAs), and stool microbiota were tested at baseline and day 15. A 6\u2010month follow\u2010up with serious adverse event (SAE) analysis was performed. Twenty patients with AUD\u2010related cirrhosis (65\u00a0\u00b1\u00a06.4\u00a0years, all men, Model for End\u2010Stage Liver Disease 8.9\u00a0\u00b1\u00a02.7) with similar demographics, cirrhosis, and AUD severity were included. Craving reduced significantly in 90% of FMT versus 30% in placebo at day 15 (<jats:italic toggle=\"yes\">P<\/jats:italic>\u00a0=\u00a00.02) with lower urinary ethylglucuronide\/creatinine (<jats:italic toggle=\"yes\">P<\/jats:italic>\u00a0=\u00a00.03) and improved cognition and psychosocial quality of life. There was reduction in serum IL\u20106 and lipopolysaccharide\u2010binding protein and increased butyrate\/isobutyrate compared with baseline in FMT but not placebo. Microbial diversity increased with higher <jats:italic toggle=\"yes\">Ruminococcaceae<\/jats:italic> and other SCFAs, producing taxa following FMT but not placebo, which were linked with SCFA levels. At 6\u00a0months, patients with any SAEs (8 vs. 2, <jats:italic toggle=\"yes\">P<\/jats:italic>\u00a0=\u00a00.02), AUD\u2010related SAEs (7 vs. 1, <jats:italic toggle=\"yes\">P<\/jats:italic>\u00a0=\u00a00.02), and SAEs\/patient (median [interquartile range], 1.5 [1.25] vs. 0 [0.25] in FMT, <jats:italic toggle=\"yes\">P<\/jats:italic>\u00a0=\u00a00.02) were higher in placebo versus FMT.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Conclusions<\/jats:title>\n            <jats:p>This phase 1 trial shows that FMT is safe and associated with short\u2010term reduction in alcohol craving and consumption with favorable microbial changes versus placebo in patients with alcohol\u2010associated cirrhosis with alcohol misuse. There was also a reduction in AUD\u2010related events over 6\u00a0months in patients assigned to FMT.<\/jats:p>\n          <\/jats:sec>","DOI":"10.1002\/hep.31496","type":"journal-article","created":{"date-parts":[[2020,8,4]],"date-time":"2020-08-04T16:46:17Z","timestamp":1596559577000},"page":"1688-1700","update-policy":"https:\/\/doi.org\/10.1097\/lww.0000000000001000","source":"Crossref","is-referenced-by-count":246,"title":["A Randomized Clinical Trial of Fecal Microbiota Transplant for Alcohol Use Disorder"],"prefix":"10.1097","volume":"73","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-4928-3681","authenticated-orcid":false,"given":"Jasmohan S.","family":"Bajaj","sequence":"first","affiliation":[{"name":"Division of Gastroenterology, Hepatology and Nutrition,Virginia Commonwealth University and Central Virginia Veterans Healthcare System,Richmond,VA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Edith 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