Fecal Microbiota Transplantation in Chronic Pouchitis : A Randomized, Parallel, Double-Blinded Clinical Trial

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Karjalainen , E K , Renkonen-Sinisalo , L , Satokari , R , Mustonen , H , Ristimäki , A , Arkkila , P & Lepistö , A H 2021 , ' Fecal Microbiota Transplantation in Chronic Pouchitis : A Randomized, Parallel, Double-Blinded Clinical Trial ' , Inflammatory Bowel Diseases , vol. 27 , no. 11 , pp. 1766-1772 . https://doi.org/10.1093/ibd/izab001

Title: Fecal Microbiota Transplantation in Chronic Pouchitis : A Randomized, Parallel, Double-Blinded Clinical Trial
Author: Karjalainen, Essi K.; Renkonen-Sinisalo, Laura; Satokari, Reetta; Mustonen, Harri; Ristimäki, Ari; Arkkila, Perttu; Lepistö, Anna H.
Contributor organization: II kirurgian klinikka
HUS Abdominal Center
Department of Surgery
Reetta Maria Satokari / Principal Investigator
HUMI - Human Microbiome Research
Clinicum
University of Helsinki
Department of Pathology
HUSLAB
Medicum
HUS Diagnostic Center
Department of Medicine
Gastroenterologian yksikkö
Date: 2021-11
Language: eng
Number of pages: 7
Belongs to series: Inflammatory Bowel Diseases
ISSN: 1078-0998
DOI: https://doi.org/10.1093/ibd/izab001
URI: http://hdl.handle.net/10138/337322
Abstract: Background: In ulcerative colitis, a pouchitis is the most common long-term adverse effect after proctocolectomy and ilea! pouch-anal anastomosis. Approximately 5% of patients develop chronic antibiotic-dependent or antibiotic-refractory pouchitis without any effective treatment. The aim of this trial was to investigate the efficacy and safety of fecal microbiota transplantation in the treatment of chronic pouchitis. Methods: This was a single-center, double-blinded, parallel group trial comparing donor fecal microbiota transplantation with placebo (autologous transplant) in chronic pouchitis.Twenty-six patients were recruited at the Helsinki University Hospital between December 2017 and August 2018 and were randomly allocated a 1:1 ratio to either donor fecal microbiota transplantation or placebo. The protocol included 2 transplantations into the pouch on weeks 0 and 4, and patients were followed up for 52 weeks. Results: Nine patients in the intervention group and 8 patients in the placebo group relapsed during the 52-week follow-up, and the relapsefree survival did not differ between the groups (P = 0.183, log-rank; hazard ratio, 1.90 [95% confidence interval, 0.73-4.98; P = 0.1901). In the subgroup analysis of patients using continuous antibiotics before the study, the relapse-free survival was shorter in the intervention group (P= 0.004, log-rank; hazard ratio, 13.08 [95% confidence interval, 1.47-116.60; P= 0.0211). No major adverse effects were reported. Conclusions: The fecal microbiota transplantation treatment regime used in our study was not effective in the treatment of chronic pouchitis. The safety profile of fecal microbiota transplantation was good.
Subject: chronic pouchitis
fecal microbiota transplantation
ulcerative colitis
RESTORATIVE PROCTOCOLECTOMY
ULCERATIVE-COLITIS
ANAL ANASTOMOSIS
THERAPY
VEDOLIZUMAB
EFFICACY
FMT
3121 General medicine, internal medicine and other clinical medicine
3111 Biomedicine
Peer reviewed: Yes
Rights: cc_by_nc
Usage restriction: openAccess
Self-archived version: publishedVersion


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