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

NCT03254823 | Completed

• 1 other identifier: 17/LO/1102
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Myalgic Encephalomyelitis; Chronic Fatigue Syndrome

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Measurement of autoimmunity

  3 years

Study Arms (2)

Severe ME/CFS patients

patients with a clinical diagnosis of ME/CFS and are house or bed bound.

Household controls

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.

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of East Anglia: lead
• Quadram Institute Bioscience: collaborator
• Invest in ME Research UK: collaborator

Study Sites (1)

Quadram Institute

Norwich, NR4 7UA, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

faecal samples serum plasma peripheral blood mononuclear cells

MeSH Terms

Conditions

Fatigue Syndrome, Chronic

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Encephalomyelitis; Neuroinflammatory Diseases; Nervous System Diseases; Neuromuscular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Simon Carding

  Quadram Institute Bioscience

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2017
• First Posted: August 21, 2017
• Study Start: August 9, 2017
• Primary Completion: August 30, 2022
• Study Completion: August 30, 2022
• Last Updated: March 30, 2025

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)