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Trial record 28 of 112 for:    Chronic Fatigue Syndrome

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
Sponsor:
Collaborators:
Quadram Institute Bioscience
Invest in ME Research UK
Information provided by (Responsible Party):
University of East Anglia

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.

Condition or disease
Myalgic Encephalomyelitis Chronic Fatigue Syndrome

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.


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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Other
Time Perspective: Other
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

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. 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.

  2. 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.

  3. Expression of microbial and viral DNA/RNA [ Time Frame: 3 years ]
    To identify the bacterial, fungal and virus populations in stool samples.


Secondary Outcome Measures :
  1. 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
faecal samples serum plasma peripheral blood mononuclear cells


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Severe ME/CFS patient attending Epsom and St Helier CFS Clinic will be identified by the Director of the clinic, Dr Bansal. CRN Eastern will notify general practitioners and occupational therapists of the study. They will then identify severe ME/CFS patients in the East of England.

Household controls will be recruited through severe ME/CFS patients participating in the study.

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.

Information from the National Library of Medicine

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


Locations
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United Kingdom
Quadram Institute
Norwich, United Kingdom, NR4 7UA
Sponsors and Collaborators
University of East Anglia
Quadram Institute Bioscience
Invest in ME Research UK
Investigators
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Principal Investigator: Simon Carding Quadram Institute Bioscience

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Responsible Party: University of East Anglia
ClinicalTrials.gov Identifier: NCT03254823     History of Changes
Other Study ID Numbers: 17/LO/1102
First Posted: August 21, 2017    Key Record Dates
Last Update Posted: September 26, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Fatigue Syndrome, Chronic
Syndrome
Fatigue
Myalgia
Encephalomyelitis
Disease
Pathologic Processes
Signs and Symptoms
Virus Diseases
Muscular Diseases
Musculoskeletal Diseases
Central Nervous System Diseases
Nervous System Diseases
Neuromuscular Diseases
Central Nervous System Infections
Musculoskeletal Pain
Pain
Neurologic Manifestations