Autoimmunity in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome
Research type
Research Study
Full title
Defining autoimmune aspects of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)
IRAS ID
218545
Contact name
Katharine Seton
Contact email
Sponsor organisation
Quadram Institute Bioscience
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 3 months, 19 days
Research summary
Little is known about the cause of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS). This study investigates whether there is an immune response against gut microbes or food and parts of the body in severe ME/CFS patients. Severe ME/CFS patients will be compared to household controls to identify disease specific alterations in the immune response to gut microbes.
Both existing samples and new samples will be used for this study. Existing samples will be acquired from the Norwich Biorepository and have been collected by a previous study addressing similar research questions at the Quadram Institute Bioscience.
New samples will be collected from severe ME/CFS patients identified by Epsom and St Helier CFS Service and the Clinical Research Network Eastern. Information sheets will be posted by health professionals to eligible patients. Interested patients arrange a telephone call with the research team to receive more information about the study. Volunteers still interested after the 72 hour consideration period arrange a home visit to be consented.
Household controls will be recruited through patients participating in the study. The patient identifies and informs potential household controls of the study using information sheets provided by their health professional. Household controls willing to participate in the study will be taken through an eligibility questionnaire with GCP trained researchers to ensure exclusion of appropriate individuals; such as those who suffer from conditions affecting to gut, immune system or diagnosed with anxiety, and anyone receiving immunomodulatory drugs, statins, beta blockers, steroids or antibiotics/probiotics (within the last six weeks).Six stool and blood samples will be collected over three years. 48 hour food diaries will be completed prior to each stool sample collection.
The study is based at the Quadram Institute Bioscience and the University of East Anglia (UEA). The research is funded by the UEA and Invest in ME Research UK.
REC name
London - Hampstead Research Ethics Committee
REC reference
17/LO/1102
Date of REC Opinion
29 Jun 2017
REC opinion
Favourable Opinion