Autoimmunity in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)
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|ClinicalTrials.gov Identifier: NCT03254823|
Recruitment Status : Enrolling by invitation
First Posted : August 21, 2017
Last Update Posted : September 26, 2019
|Condition or disease|
|Myalgic Encephalomyelitis Chronic Fatigue Syndrome|
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|
|Estimated Enrollment :||20 participants|
|Official Title:||Defining Autoimmune Aspects of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)|
|Actual Study Start Date :||March 28, 2018|
|Estimated Primary Completion Date :||September 30, 2020|
|Estimated Study Completion Date :||September 30, 2020|
Severe ME/CFS patients
patients with a clinical diagnosis of ME/CFS and are house or bed bound.
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.
- Measurement of antibody levels [ Time Frame: 3 years ]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.
- Measurement of cellular immune responses [ Time Frame: 3 years ]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.
- Expression of microbial and viral DNA/RNA [ Time Frame: 3 years ]To identify the bacterial, fungal and virus populations in stool samples.
- Measurement of autoimmunity [ Time Frame: 3 years ]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.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03254823
|Norwich, United Kingdom, NR4 7UA|
|Principal Investigator:||Simon Carding||Quadram Institute Bioscience|