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Trial record 28 of 117 for:    Chronic Fatigue Syndrome

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date July 26, 2017
First Posted Date August 21, 2017
Last Update Posted Date September 26, 2019
Actual Study Start Date March 28, 2018
Estimated Primary Completion Date September 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 18, 2017)
  • 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.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03254823 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: August 18, 2017)
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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
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
Study Design Observational Model: Other
Time Perspective: Other
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
faecal samples serum plasma peripheral blood mononuclear cells
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.

Condition
  • Myalgic Encephalomyelitis
  • Chronic Fatigue Syndrome
Intervention Not Provided
Study Groups/Cohorts
  • 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Enrolling by invitation
Estimated Enrollment
 (submitted: August 18, 2017)
20
Original Estimated Enrollment Same as current
Estimated Study Completion Date September 30, 2020
Estimated Primary Completion Date September 30, 2020   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number NCT03254823
Other Study ID Numbers 17/LO/1102
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party University of East Anglia
Study Sponsor University of East Anglia
Collaborators
  • Quadram Institute Bioscience
  • Invest in ME Research UK
Investigators
Principal Investigator: Simon Carding Quadram Institute Bioscience
PRS Account University of East Anglia
Verification Date September 2019