xml: <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/NCT05975034</url>
    </required_header>
    <id_info>
      <org_study_id>ER45883322</org_study_id>
      <nct_id>NCT05975034</nct_id>
    </id_info>
    <brief_title>Investigation of the Use of a Probiotic Supplement in People With Long COVID</brief_title>
    <official_title>Investigation of the Use of a Probiotic Supplement in People With Long COVID</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Sheffield Hallam University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Symprove UK</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Biomesight</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Sheffield Hallam University</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 is a double-blinded randomised trial to assess the efficacy of a probiotic&#xD;
        supplement in alleviating symptoms in people with Long COVID.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        240 participants with Long COVID will be randomly assigned to either a probiotic or placebo&#xD;
        group in a 1:1 ratio for twelve weeks. Participants will track symptoms using an app for&#xD;
        three weeks before the study, and for the last three weeks of the treatment. Participants&#xD;
        will answer online questionnaires about their symptoms at 0, 4, 8, and 12 weeks. A subgroup&#xD;
        of 60 participants will attend the laboratory for blood tests, cognitive function tests and&#xD;
        gut microbiome analysis at 0 and 12 weeks. This group will also wear activity trackers for&#xD;
        two weeks before the study, and for the final two weeks of the study.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">June 12, 2023</start_date>
    <completion_date type="Anticipated">December 11, 2023</completion_date>
    <primary_completion_date type="Anticipated">December 11, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>Double-blinded randomised trial</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
      <masking_description>Computerised randomisation by a researcher in a separate department, probiotic/placebo packaged in identical bottles (label indicates group A or B). Probiotic/placebo delivered directly from supplier to participants (without involvement of the investigators).</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Fatigue severity scale (FSS)</measure>
      <time_frame>12 weeks</time_frame>
      <description>9-item scale which measures the severity of fatigue and its effect on a person's activities and lifestyle</description>
    </primary_outcome>
    <primary_outcome>
      <measure>FACIT fatigue scale</measure>
      <time_frame>12 weeks</time_frame>
      <description>Measure that assesses self-reported fatigue and its impact upon daily activities and function</description>
    </primary_outcome>
    <primary_outcome>
      <measure>EQ-5D-5L</measure>
      <time_frame>12 weeks</time_frame>
      <description>Multi-attribute generic health status measure</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Ability to Participate in Social Roles and Activities - PROMIS Short Form 8a</measure>
      <time_frame>12 weeks</time_frame>
      <description>Evaluation of ability to participate in social roles and activities</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Ecological Momentary Assessment (EMA) app</measure>
      <time_frame>12 weeks</time_frame>
      <description>Symptom data collected using an app (sleep, fatigue, pain, breathlessness, light-headedness, cognitive difficulties)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>IBS-SSS</measure>
      <time_frame>12 weeks</time_frame>
      <description>Composite score of abdominal pain, number of days with abdominal pain, bloating/distension, satisfaction with bowel habits, and IBS-related quality of life</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Gastrointestinal Symptom Rating Scale</measure>
      <time_frame>12 weeks</time_frame>
      <description>15 items in five symptom clusters: Reflux, Abdominal pain, Indigestion, Diarrhoea and Constipation</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>MRC Dyspnoea scale</measure>
      <time_frame>12 weeks</time_frame>
      <description>Assesses the degree of functional disability due to dyspnoea</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>International. Physical Activity Questionnaire (short form)</measure>
      <time_frame>12 weeks</time_frame>
      <description>Assesses moderate-to-vigorous physical activity and sedentary behaviour</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Accelerometery data</measure>
      <time_frame>12 weeks</time_frame>
      <description>Longitudinal measurement of movement</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cambridge Neuropsychological Test Automated Battery (CANTAB)</measure>
      <time_frame>12 weeks</time_frame>
      <description>Computer-based cognitive assessment system</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>16S rRNA sequencing</measure>
      <time_frame>12 weeks</time_frame>
      <description>Analysis of the composition and diversity of the gut microbiome</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Analysis of inflammatory markers</measure>
      <time_frame>12 weeks</time_frame>
      <description>Measurement of cytokines (including IL-8, IL-6) by ELISA</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">240</enrollment>
    <condition>Long COVID</condition>
    <arm_group>
      <arm_group_label>Probiotic</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants assigned to the probiotic group.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Participants assigned to the placebo group.</description>
    </arm_group>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>Probiotic</intervention_name>
      <description>Probiotic taken daily for 12 weeks.</description>
      <arm_group_label>Probiotic</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>Placebo taken daily for 12 weeks.</description>
      <arm_group_label>Placebo</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria: Long COVID defined as National Institute for Health and Care Excellence&#xD;
          (NICE) criteria for Long COVID (Persistent symptoms at least 12 weeks after a confirmed or&#xD;
          suspected Covid-19 infection).&#xD;
  &#xD;
          -&#xD;
  &#xD;
          Exclusion Criteria: Significant co-morbidities - no pre-existing diagnosis of hypertension,&#xD;
          diabetes, cerebrovascular, cardiovascular or peripheral vascular disease, coagulopathy or&#xD;
          haematological disorder or current or recent cancer.&#xD;
  &#xD;
          -&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Caroline Dalton, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Sheffield Hallam University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Caroline Dalton, PhD</last_name>
      <phone>44-114-225-3695</phone>
      <email>c.f.dalton@shu.ac.uk</email>
    </overall_contact>
    <location>
      <facility>
        <name>Sheffield Hallam University</name>
        <address>
          <city>Sheffield</city>
          <zip>S1 1WB</zip>
          <country>United Kingdom</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Caroline Dalton, PhD</last_name>
        <phone>44-114-225-3695</phone>
        <email>c.f.dalton@shu.ac.uk</email>
      </contact>
    </location>
    <location_countries>
      <country>United Kingdom</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 2, 2023</study_first_submitted>
    <study_first_submitted_qc>August 2, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 3, 2023</study_first_posted>
    <last_update_submitted>August 2, 2023</last_update_submitted>
    <last_update_submitted_qc>August 2, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 3, 2023</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>Post-Acute COVID-19 Syndrome</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05975034
  org study id: ER45883322
  nct id: NCT05975034
  lead sponsor: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This study is a double-blinded randomised trial to assess the efficacy of a probiotic
        supplement in alleviating symptoms in people with Long COVID.
  240 participants with Long COVID will be randomly assigned to either a probiotic or placebo
        group in a 1:1 ratio for twelve weeks. Participants will track symptoms using an app for
        three weeks before the study, and for the last three weeks of the treatment. Participants
        will answer online questionnaires about their symptoms at 0, 4, 8, and 12 weeks. A subgroup
        of 60 participants will attend the laboratory for blood tests, cognitive function tests and
        gut microbiome analysis at 0 and 12 weeks. This group will also wear activity trackers for
        two weeks before the study, and for the final two weeks of the study.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Double-blinded randomised trial
  primary purpose: Treatment
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  masking description: Computerised randomisation by a researcher in a separate department, probiotic/placebo packaged in identical bottles (label indicates group A or B). Probiotic/placebo delivered directly from supplier to participants (without involvement of the investigators).
  measure: Fatigue severity scale (FSS)
  time frame: 12 weeks
  description: 9-item scale which measures the severity of fatigue and its effect on a person's activities and lifestyle
  measure: FACIT fatigue scale
  time frame: 12 weeks
  description: Measure that assesses self-reported fatigue and its impact upon daily activities and function
  measure: EQ-5D-5L
  time frame: 12 weeks
  description: Multi-attribute generic health status measure
  measure: Ability to Participate in Social Roles and Activities - PROMIS Short Form 8a
  time frame: 12 weeks
  description: Evaluation of ability to participate in social roles and activities
  measure: Ecological Momentary Assessment (EMA) app
  time frame: 12 weeks
  description: Symptom data collected using an app (sleep, fatigue, pain, breathlessness, light-headedness, cognitive difficulties)
  measure: IBS-SSS
  time frame: 12 weeks
  description: Composite score of abdominal pain, number of days with abdominal pain, bloating/distension, satisfaction with bowel habits, and IBS-related quality of life
  measure: Gastrointestinal Symptom Rating Scale
  time frame: 12 weeks
  description: 15 items in five symptom clusters: Reflux, Abdominal pain, Indigestion, Diarrhoea and Constipation
  measure: MRC Dyspnoea scale
  time frame: 12 weeks
  description: Assesses the degree of functional disability due to dyspnoea
  measure: International. Physical Activity Questionnaire (short form)
  time frame: 12 weeks
  description: Assesses moderate-to-vigorous physical activity and sedentary behaviour
  measure: Accelerometery data
  time frame: 12 weeks
  description: Longitudinal measurement of movement
  measure: Cambridge Neuropsychological Test Automated Battery (CANTAB)
  time frame: 12 weeks
  description: Computer-based cognitive assessment system
  measure: 16S rRNA sequencing
  time frame: 12 weeks
  description: Analysis of the composition and diversity of the gut microbiome
  measure: Analysis of inflammatory markers
  time frame: 12 weeks
  description: Measurement of cytokines (including IL-8, IL-6) by ELISA
  arm group label: Probiotic
  arm group type: Experimental
  description: Participants assigned to the probiotic group.
  arm group label: Placebo
  arm group type: Placebo Comparator
  description: Participants assigned to the placebo group.
  intervention type: Dietary Supplement
  intervention name: Probiotic
  description: Probiotic taken daily for 12 weeks.
  arm group label: Probiotic
  intervention type: Dietary Supplement
  intervention name: Placebo
  description: Placebo taken daily for 12 weeks.
  arm group label: Placebo
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Caroline Dalton, PhD
  role: Principal Investigator
  affiliation: Sheffield Hallam University
  last name: Caroline Dalton, PhD
  phone: 44-114-225-3695
  email: c.f.dalton@shu.ac.uk
  facility: 
  status: Recruiting
  contact: 
  country: United Kingdom
  responsible party type: Sponsor
  mesh term: Post-Acute COVID-19 Syndrome
  sharing ipd: No