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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03254823
• Date of registration: 26/07/2017
• Prospective Registration: Yes
• Primary sponsor: University of East Anglia
• Public title: Autoimmunity in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)
• Scientific title: Defining Autoimmune Aspects of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)
• Date of first enrolment: March 28, 2018
• Target sample size: 20
• Recruitment status: Enrolling by invitation
• URL: https://clinicaltrials.gov/show/NCT03254823
• Study type: Observational

Countries of recruitment

United Kingdom

Contacts

• Name: Simon Carding
• Affiliation: Quadram Institute Bioscience

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 70 Years
Gender: All

Health Condition(s) or Problem(s) studied

Chronic Fatigue Syndrome

Myalgic Encephalomyelitis

Primary Outcome(s)

Measurement of cellular immune responses [Time Frame: 3 years]

Expression of microbial and viral DNA/RNA [Time Frame: 3 years]

Measurement of antibody levels [Time Frame: 3 years]

Secondary Outcome(s)

Measurement of autoimmunity [Time Frame: 3 years]

Secondary ID(s)

17/LO/1102

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Invest in ME Research UK

Quadram Institute Bioscience