Scientific Title:

RESTORE-ME: A double blinded, placebo controlled, parallel group trial to determine the efficacy and safety of Faecal Microbiome Transplantation (FMT) as a treatment for Myalgic Encephalomyelitis (ME)

Chief Scientific Lead:

Professor Simon Carding, Head, Gut Microbes and Health Institute Strategic Programme, Quadram Institute

Funder:

Invest in ME Research

Sponsor:

Norfolk and Norwich University Hospitals NHS Trust (NNUH)

Health Condition or Problem Studied:

Myalgic encephalomyelitis (ME)

Intervention:

• Intervention group: Participants will receive a single (minimum 70g) aliquot of donor Faecal matter administered via flexible sigmoidoscopy at baseline visit – the Faecal Microbiome Transplantation (FMT).

• Control group: Participant will receive a placebo ‘sham’ Faecal Microbiome Transplantation (FMT), an auto infusion of their own previously collected and prepared sample, administered flexible sigmoidoscopy at baseline visit.

Study Design:

This is an interventional, randomised, double blinded, parallel, phase IIb trial to determine efficacy and safety of FMT in patients.

Target Sample Size:

160

Status:

In set up