FMT Clinical Trial
To determine the efficacy of faecal microbiome transplantation for ME: RESTORE-ME
Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) is a heterogeneous disease of unknown aetiology and pathogenesis. There is no effective therapeutic strategy currently available for patients with this disease.
While numerous therapies have been utilised to ease the symptoms of myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS), it appears that once established it is hard to cure and fewer than 6% of patients return to premorbid levels of health (Cairns and Hotopf, 2005). As such alternative therapies need to be investigated in this debilitating condition.
Professor Simon Carding, Group Leader, Quadram Institute, Norwich and Carding Lab
University of East Anglia
Norfolk and Norwich University Hospital
A promising therapeutic target in ME/CFS is the intestinal microbiota that contains vast numbers of bacteria, viruses, archaea and eukaryotes such as fungi, helminths, and protozoa that collectively promote and maintain life-long health.
Alterations in the intestinal microbiota (dysbiosis) are associated with various chronic diseases, including ME/CFS, that affect the gastrointestinal tract (GIT) and other organs including the brain (Carding et al., 2015). Recent studies identifying changes in the bacterial and viral component of the faecal microbiome in ME/CFS patients (Newberry et al., 2018) have led to the suggestion that intestinal microbial dysbiosis contributes to gastrointestinal symptoms such as irritable bowel syndrome (IBS) seen in the majority (>90%) of ME/CFS patients(Aaron et al., 2000).
Other diseases characterised by intestinal microbial dysbiosis including recalcitrant Clostridium difficile infection (rCDI), inflammatory bowel disease (IBD) and IBS, have benefited from the wholesale replacement of the dysbiotic microbiota by faecal microbiota transplantation (FMT) (Smits et al., 2013).
Considering that a significant proportion of ME/CFS patients date the onset of their symptoms to a GI illness, with abdominal pain, diarrhoea and sometimes vomiting, FMT may be helpful in these patients. A study undertaken in a single centre in Australia has reported significant clinical improvement in 70% of ME/CFS patients administered an FMT (Borody et al., 2012).
The Aim of the RESTORE-ME study is to undertake a clinical feasibility study of FMT in ME/CFS and determine if a full clinical trial is justified. This will be achieved by providing evidence for efficacy in this patient group, a mechanistic understanding of FMT in ME/CFS, the acceptability of the treatment for patients, the measurement properties of outcome measures, and to provide bounds for efficacy.
Funding is via Invest in ME Research (currently 50%).
How Does This Align With IiME Objectives/What is the Justification for Project
The aim of Invest in ME Research is to bring forward a logical basis for treatment of ME based on ‘solid’ biomedical-based research and this project fulfills that brief.