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
Invest in ME Research
Norfolk and Norwich University Hospitals NHS Trust (NNUH)
Health Condition or Problem Studied:
Myalgic encephalomyelitis (ME)
• 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.
This is an interventional, randomised, double blinded, parallel, phase IIb trial to determine efficacy and safety of FMT in patients.
Target Sample Size:
In set up