Chronic Fatigue Syndrome Clinical Trial
Official title:
Defining Autoimmune Aspects of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)
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.
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.
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