Fecal microbiota transplantation for treatment of moderate to severe ulcerative colitis: a living systematic review protocol

Abstract

Background: Several primary studies and systematic reviews (SRs) have been published over the past 10 years to assess the safety and effectiveness of fecal microbiota transplantation (FMT) as a treatment for ulcerative colitis. The objective of this review is to evaluate the efficacy and safety of fecal microbiota transplantation for adult patients with moderate or severe ulcerative colitis. Methods: We will carry out a living systematic review including only randomized controlled trials (RCT) irrespective of publication type, year and language of publication. To prioritize the intervention (TFM administration route), comparisons (placebo, alternative treatment or no treatment) and outcomes (clinical remission, clinical relapse, serious adverse events, clinical response, free time without corticosteroid treatment and health related quality of life) more relevant for supporting the clinical decisions in the treatment of UC patients, we will perform a Delphi process conducted by an expert panel in the field of gastroenterology and colorectal surgery. Searches will be performed in Epistemonikos database and results will be incorporated into the L·OVE platform identified as “Fecal microbiota transplant in ulcerative colitis”. We will evaluate the risk of bias of the included randomized trials using the ROB-2 tool and assess the certainty of evidence using the GRADE approach. We will monitor the L ·OVE platform every two months searching for relevant trials that could imply changes in the available evidence. The living process will end after 12 months of surveillance. PROSPERO registration: CRD42021257579 (29/10/2021).