<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03254823</url>
  </required_header>
  <id_info>
    <org_study_id>17/LO/1102</org_study_id>
    <nct_id>NCT03254823</nct_id>
  </id_info>
  <brief_title>Autoimmunity in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)</brief_title>
  <official_title>Defining Autoimmune Aspects of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of East Anglia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Quadram Institute Bioscience</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Invest in ME Research UK</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of East Anglia</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study investigates whether there is an immune response directed against gut microbes or&#xD;
      food and parts of the body in severe Myalgic Encephalomyelitis/Chronic Fatigue Syndrome&#xD;
      (ME/CFS) patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Severe Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) patients will be&#xD;
      identified by Epsom and St Helier CFS Service and the Clinical Research Network Eastern.&#xD;
      Information sheets will be posted by health professionals to eligible patients. Interested&#xD;
      patients are asked to arrange a telephone call with the research team to receive more&#xD;
      information about the study. Volunteers still interested after the 72 hour consideration&#xD;
      period arrange a home visit to be taken through the consenting process.&#xD;
&#xD;
      Household controls will be recruited through patients participating in the study. Patients&#xD;
      invited will be provided with information about household controls. The patient identifies&#xD;
      and informs potential household controls of the study using information sheets provided by&#xD;
      their health professional. Household controls willing to participate in the study will be&#xD;
      taken through an eligibility questionnaire with GCP trained researchers.&#xD;
&#xD;
      Six stool and blood samples will be collected over the three year study period. Stool and&#xD;
      blood samples need to be collected within 24 hours of each other, during home visits. 48 hour&#xD;
      food diaries will be completed prior to each stool sample collection.&#xD;
&#xD;
      The study is based at the Quadram Institute and the University of East Anglia (UEA). The&#xD;
      research is funded by the UEA and Invest in ME Research UK.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date type="Actual">March 28, 2018</start_date>
  <completion_date type="Anticipated">September 30, 2020</completion_date>
  <primary_completion_date type="Anticipated">September 30, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Measurement of antibody levels</measure>
    <time_frame>3 years</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Measurement of cellular immune responses</measure>
    <time_frame>3 years</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Expression of microbial and viral DNA/RNA</measure>
    <time_frame>3 years</time_frame>
    <description>To identify the bacterial, fungal and virus populations in stool samples.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Measurement of autoimmunity</measure>
    <time_frame>3 years</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Myalgic Encephalomyelitis</condition>
  <condition>Chronic Fatigue Syndrome</condition>
  <arm_group>
    <arm_group_label>Severe ME/CFS patients</arm_group_label>
    <description>patients with a clinical diagnosis of ME/CFS and are house or bed bound.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Household controls</arm_group_label>
    <description>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.</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      faecal samples serum plasma peripheral blood mononuclear cells&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Severe ME/CFS patient attending Epsom and St Helier CFS Clinic will be identified by the&#xD;
        Director of the clinic, Dr Bansal. CRN Eastern will notify general practitioners and&#xD;
        occupational therapists of the study. They will then identify severe ME/CFS patients in the&#xD;
        East of England.&#xD;
&#xD;
        Household controls will be recruited through severe ME/CFS patients participating in the&#xD;
        study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  severe ME/CFS patients: men or women aged 18 to 70 years with a clinical diagnosis of&#xD;
             severe ME/CFS patients&#xD;
&#xD;
          -  household controls: men or women aged 18 to 70 years, no current or on-going medical&#xD;
             conditions. Has to be either related/non-related, living in the same household or in&#xD;
             close proximity to, or providing care to the severe ME/CFS patient they are paired&#xD;
             with.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  severe ME/CFS patients: the presence of significant anxiety or depression. Have&#xD;
             received probiotics or antibiotics up to six weeks before joining the study.&#xD;
&#xD;
          -  Household controls: The presence of long term medical conditions, in particular,&#xD;
             affecting the stomach or bowel. Previously diagnosed with autoimmune diseases, for&#xD;
             example, systemic lupus erythematous or rheumatoid arthritis. Suffer from significant&#xD;
             anxiety or depression. In recipient of immunomodulatory drugs, statins, beta blocker&#xD;
             or steroids. Have received probiotics or antibiotics up to six weeks before joining&#xD;
             the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Simon Carding</last_name>
    <role>Principal Investigator</role>
    <affiliation>Quadram Institute Bioscience</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Quadram Institute</name>
      <address>
        <city>Norwich</city>
        <zip>NR4 7UA</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>July 26, 2017</study_first_submitted>
  <study_first_submitted_qc>August 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 21, 2017</study_first_posted>
  <last_update_submitted>September 25, 2019</last_update_submitted>
  <last_update_submitted_qc>September 25, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 26, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Encephalomyelitis</mesh_term>
    <mesh_term>Fatigue Syndrome, Chronic</mesh_term>
    <mesh_term>Myalgia</mesh_term>
    <mesh_term>Syndrome</mesh_term>
    <mesh_term>Fatigue</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03254823
org study id: 17/LO/1102
nct id: NCT03254823
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
observational model: Other
time perspective: Other
measure: Measurement of antibody levels
time frame: 3 years
description: 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.
measure: Measurement of cellular immune responses
time frame: 3 years
description: 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.
measure: Expression of microbial and viral DNA/RNA
time frame: 3 years
description: To identify the bacterial, fungal and virus populations in stool samples.
measure: Measurement of autoimmunity
time frame: 3 years
description: 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.
arm group label: Severe ME/CFS patients
description: patients with a clinical diagnosis of ME/CFS and are house or bed bound.
arm group label: Household controls
description: 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.
faecal samples serum plasma peripheral blood mononuclear cells
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Simon Carding
role: Principal Investigator
affiliation: Quadram Institute Bioscience
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Encephalomyelitis
mesh term: Fatigue Syndrome, Chronic
mesh term: Myalgia
mesh term: Syndrome
mesh term: Fatigue
sharing ipd: No