An observational study in Myalgic Encephalomyelitis and Chronic Fatigue Syndrome, sponsored by University of East Anglia. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-30.
Sponsored by University of East Anglia · Observational
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.
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 posted by health professionals to eligible patients. Interested patients are asked to 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 taken through the consenting process.
Household controls will be recruited through patients participating in the study. Patients invited will be provided with information about household controls. 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.
Six stool and blood samples will be collected over the three year study period. Stool and blood samples need to be collected within 24 hours of each other, during home visits. 48 hour food diaries will be completed prior to each stool sample collection.
The study is based at the Quadram Institute and the University of East Anglia (UEA). The research is funded by the UEA and Invest in ME Research UK.
Severe ME/CFS patient attending Epsom and St Helier CFS Clinic will be identified by the Director of the clinic, Dr Bansal. CRN Eastern will notify general practitioners and occupational therapists of the study. They will then identify severe ME/CFS patients in the East of England.
Household controls will be recruited through severe ME/CFS patients participating in the study.
Exclusion Criteria:
patients with a clinical diagnosis of ME/CFS and are house or bed bound.
Healthy human participants who are either related/non-related to, living in the same household or in close proximity to, or providing care to the severe ME/CFS patient they are paired with. They are used as an environmental control.
Measurement of antibody levels
Measurement of serum antibodies that are reactive with intestinal microbes or foods. Antibody levels will reflect the presence of an immune response directed against gut microbes in severe ME/CFS patients.
Time frame: 3 years
Measurement of cellular immune responses
Measurement of memory T and memory B cells (from peripheral blood mononuclear cells in the blood) specific to gut microbes (from stool sample). The presence of memory T and B cells will indicate a systemic (whole body) immune response directed against gut microbes in severe ME/CFS patients.
Time frame: 3 years
Expression of microbial and viral DNA/RNA
To identify the bacterial, fungal and virus populations in stool samples.
Time frame: 3 years
Measurement of autoimmunity
Measurement of serum antibodies and immune cells that are reactive with human cells, such as cells of the central nervous system. The presence of an immune response against human cells and human cell proteins is indicative of the presence of autoimmunity.
Time frame: 3 years
Plan to share: No
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This study is completed, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.
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University of East Anglia