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

Autor:	Karjalainen EK; Department of Gastrointestinal Surgery, Helsinki University Hospital, Helsinki, Finland., Renkonen-Sinisalo L; Department of Gastrointestinal Surgery, Helsinki University Hospital, Helsinki, Finland.; Genome-Scale Biology Research Program, Research Programs Unit, University of Helsinki, Helsinki, Finland., Satokari R; Human Microbiome Research Program, Faculty of Medicine, University of Helsinki, Helsinki, Finland., Mustonen H; Department of Gastrointestinal Surgery, Helsinki University Hospital, Helsinki, Finland.; University of Helsinki, Helsinki, Finland., Ristimäki A; Department of Pathology, Medicum, Faculty of Medicine, University of Helsinki, Helsinki, Finland.; HUS Diagnostic Center, HUSLAB, Pathology, Helsinki University Hospital, Helsinki, Finland.; Applied Tumor Genomics Research Program, Research Programs Unit, Faculty of Medicine, University of Helsinki, Helsinki, Finland., Arkkila P; Department of Gastroenterology, Helsinki University Hospital, Helsinki, Finland., Lepistö AH; Department of Gastrointestinal Surgery, Helsinki University Hospital, Helsinki, Finland.; Genome-Scale Biology Research Program, Research Programs Unit, University of Helsinki, Helsinki, Finland.
Jazyk:	angličtina
Zdroj:	Inflammatory bowel diseases [Inflamm Bowel Dis] 2021 Oct 20; Vol. 27 (11), pp. 1766-1772.
DOI:	10.1093/ibd/izab001
Abstrakt:	Background: In ulcerative colitis, a pouchitis is the most common long-term adverse effect after proctocolectomy and ileal 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 relapse-free survival did not differ between the groups (P = 0.183, log-rank; hazard ratio, 1.90 [95% confidence interval, 0.73-4.98; P = 0.190]). 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 = 0.021]). 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. Clinicaltrials.gov Identifier: NCT03378921. (© 2021 Crohn’s & Colitis Foundation. Published by Oxford University Press on behalf of Crohn’s & Colitis Foundation.)
Databáze:	MEDLINE
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