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

NCT ID: NCT03254823

Last Updated: 2025-03-30

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 10 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-08-09
• Study Completion Date: 2022-08-30

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 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.

Conditions

Myalgic Encephalomyelitis; Chronic Fatigue Syndrome

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: OTHER

Study Groups

Severe ME/CFS patients

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

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Quadram Institute Bioscience

OTHER

Sponsor Role: collaborator

Invest in ME Research UK

UNKNOWN

Sponsor Role: collaborator

University of East Anglia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Simon Carding

Role: PRINCIPAL_INVESTIGATOR

Quadram Institute Bioscience

Locations

Quadram Institute

Norwich, , United Kingdom

Countries

United Kingdom

Other Identifiers

17/LO/1102

Identifier Type: -

Identifier Source: org_study_id