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

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Brief Title

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

Official Title

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

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.
    


Study Type

Observational


Primary Outcome

Measurement of antibody levels

Secondary Outcome

 Measurement of autoimmunity

Condition

Myalgic Encephalomyelitis


Study Arms / Comparison Groups

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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

20

Start Date

March 28, 2018

Completion Date

September 30, 2020

Primary Completion Date

September 30, 2020

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.
      

Gender

All

Ages

18 Years - 70 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Simon Carding, , 

Location Countries

United Kingdom

Location Countries

United Kingdom

Administrative Informations


NCT ID

NCT03254823

Organization ID

17/LO/1102


Responsible Party

Sponsor

Study Sponsor

University of East Anglia

Collaborators

 Quadram Institute Bioscience

Study Sponsor

Simon Carding, Principal Investigator, Quadram Institute Bioscience


Verification Date

September 2019