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

Abstract

Background: Primary studies and systematic reviews assessing the safety and effectiveness of fecal microbiota transplantation as a treatment for ulcerative colitis are being continuously published. The objective of this review is to synthesize and keep updated the evidence about the efficacy and safety of fecal microbiota transplantation for adult patients with moderate or severe ulcerative colitis through a living systematic review. Methods: We will carry out a living systematic review including only randomized controlled trials irrespective of publication type, year and language of publication. To prioritize the fecal microbiota transplantation administration route, comparators and outcomes more relevant for supporting the clinical decisions in the treatment of ulcerative colitis 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).