Status:
COMPLETED
Autoimmunity in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)
Lead Sponsor:
University of East Anglia
Collaborating Sponsors:
Quadram Institute Bioscience
Invest in ME Research UK
Conditions:
Myalgic Encephalomyelitis
Chronic Fatigue Syndrome
Eligibility:
All Genders
18-70 years
Brief Summary
This study investigates whether there is an immune response directed against gut microbes or food and parts of the body in severe Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) patients.
Detailed Description
Severe Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) patients will be identified by Epsom and St Helier CFS Service and the Clinical Research Network Eastern. Information sheets will be ...
Eligibility Criteria
Inclusion
- severe ME/CFS patients: men or women aged 18 to 70 years with a clinical diagnosis of severe ME/CFS patients
- household controls: men or women aged 18 to 70 years, no current or on-going medical conditions. Has to be either related/non-related, living in the same household or in close proximity to, or providing care to the severe ME/CFS patient they are paired with.
Exclusion
- severe ME/CFS patients: the presence of significant anxiety or depression. Have received probiotics or antibiotics up to six weeks before joining the study.
- Household controls: The presence of long term medical conditions, in particular, affecting the stomach or bowel. Previously diagnosed with autoimmune diseases, for example, systemic lupus erythematous or rheumatoid arthritis. Suffer from significant anxiety or depression. In recipient of immunomodulatory drugs, statins, beta blocker or steroids. Have received probiotics or antibiotics up to six weeks before joining the study.
Key Trial Info
Start Date :
August 9 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 30 2022
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT03254823
Start Date
August 9 2017
End Date
August 30 2022
Last Update
March 30 2025
Active Locations (1)
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1
Quadram Institute
Norwich, United Kingdom, NR4 7UA