Autoimmunity in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)

Study Overview
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Brief Summary
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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
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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.

Official Title
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Defining Autoimmune Aspects of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)

Conditions
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Myalgic Encephalomyelitis, Chronic Fatigue Syndrome

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Severe ME/CFS patients<br>patients with a clinical diagnosis of ME/CFS and are house or bed bound. | |
| Household controls<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 3 years | 
| Expression of microbial and viral DNA/RNA | To identify the bacterial, fungal and virus populations in stool samples. | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 3 years |