Randomised controlled trials of faecal microbiota transplantation in adult inpatients: a scoping review study protocol

Abstract

Abstract Introduction Recently, Health Canada and the United States Food and Drug Administration approved the use of Rebyota, a regulated faecal microbiota transplantation (FMT) product for the treatment of recurrent and refractory Clostridium difficile infections. FMT is now being studied for other acute conditions including infectious, autoimmune, metabolic and psychiatric illnesses as these conditions are also associated with significant alterations to the gut microbiota. To summarise the accumulation of this evidence base, we are conducting a scoping review of all adult inpatient randomised controlled trials to describe the populations studied, the type of FMT administered, the outcome measures assessed and the safety profile of FMT. Methods This scoping review is designed based on the step-based approach proposed by Arksey and O’Malley, with updates recommended by Peters et al multiple databases will be searched, including Medline, EMBASE and CENTRAL. Selected articles will be limited to those available in English. Two independent reviewers will perform article screening on the Covidence software as well as data abstraction using a pre-piloted Excel data extraction form. Study findings will be presented in accordance with the Preferred Reporting Items for Systematic reviews and Meta-Analyses extension for Scoping Reviews (PRISMA-ScR) guidelines. Ethics and dissemination Given the nature of the scoping review, ethics approval is not required. Our findings will be disseminated on multiple levels. We aim to present the study results at relevant Canadian and international scientific meetings. We also plan to publish the findings of this review in an open-access medical journal to reach a broad international audience. Trial registration number This protocol was registered on Open Science Framework (https://osf.io/nyzwb/overview).