Journal Article

PROFIT, a PROspective, randomised placebo controlled feasibility trial of Faecal mIcrobiota Transplantation in cirrhosis: study protocol for a single-blinded trial

O’Brien, Alastair, Patel, Vishal C, Flach, Clare, Sanchez-Fueyo, Alberto, Shawcross, Debbie, China, Louise, Douiri, Abdel, Woodhouse, Charlotte Alexandra, Goldenberg, Simon

2019

Overview

IntroductionPatients with advanced cirrhosis have enteric bacterial dysbiosis and translocation of bacteria and their products across the gut epithelial barrier. This culminates in systemic inflammation and endotoxaemia, inducing innate immune dysfunction which predisposes to infection, and development of complications such as bleeding, sepsis and hepatic encephalopathy. This feasibility study aims to assess the safety of administering faecal microbiota transplantion to patients with cirrhosis and explore the effect of the intervention on their prognosis by achieving restoration of a healthy gut microbiome.Methods and analysisA PROspective, randomised placebo controlled feasibility trial of Faecal mIcrobiota Transplantation is a single-centre, randomised, single-blinded, placebo-controlled study evaluating faecal microbiota transplantation (FMT) against placebo. Patients with advanced but stable cirrhosis with a Model for End-Stage Liver Disease score between 10 and 16 will be recruited. Twenty-four patients will be randomised to FMT plus standard of care (as per our institutional practice) and eight patients to placebo in a ratio of 3:1. Patients will be evaluated at baseline before the study intervention is administered and at 7, 30 and 90 days post-intervention to assess safety and adverse events. FMT/placebo will be administered into the jejunum within 7 days of baseline. The primary outcome measure will be safety and feasibility as assessed by recruitment rates, tolerability and safety of FMT treatment. Results will be disseminated via peer-reviewed journals and international conferences. The recruitment of the first patient occurred on 23 May 2018.Ethics and disseminationResearch Ethics approval was given by the London South East Research Ethics committee (ref 17/LO/2081).Trial registration numberNCT02862249 and EudraCT 2017-003629-13.

• Publisher: BMJ Publishing Group LTD,BMJ Publishing Group
• Subject: Alcohol / Antibiotics / Clinical trials / Evidence-based medicine / Feasibility Studies / Fecal Microbiota Transplantation - methods / Feces / Gastroenterology / Gastroenterology and Hepatology / Hepatology / Humans / Infections / Inflammatory bowel disease / Liver cirrhosis / Liver Cirrhosis - therapy / Liver diseases / Microbiota / Objectives / Prospective Studies / Randomized Controlled Trials as Topic / Single-Blind Method / Systematic review / Transplants & implants