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/NCT06013072</url>
    </required_header>
    <id_info>
      <org_study_id>2022-03-23_CFS</org_study_id>
      <nct_id>NCT06013072</nct_id>
    </id_info>
    <brief_title>Pre-probiotic Supplementation for Post-covid Fatigue Syndrome</brief_title>
    <acronym>STOPPFATIQUE</acronym>
    <official_title>The Effects of 3-month Supplementation With a Pre-probiotic on Patient- and Clinician-reported Outcomes, and Brain Tissue Metabolism in Patients With Post-covid Fatigue Syndrome: a Placebo-controlled Randomized Clinical Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Novi Sad, Faculty of Sport and Physical Education</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Novi Sad, Faculty of Sport and Physical Education</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>
        The goal of this randomized controlled double-blind parallel-group interventional trial is to&#xD;
        evaluate the effects of of dietary supplementation with a pre-probiotic on patient- and&#xD;
        clinician-reported outcomes, and brain tissue metabolism in patients with post-covid fatigue&#xD;
        syndrome.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">October 1, 2022</start_date>
    <completion_date type="Anticipated">December 31, 2023</completion_date>
    <primary_completion_date type="Anticipated">December 31, 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>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>Triple (Participant, Care Provider, Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Fatigue</measure>
      <time_frame>Change from baseline fatigue at 3 months</time_frame>
      <description>Level of fatigue as assessed by the Multidimensional Fatigue Inventory (MFI)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Brain creatine</measure>
      <time_frame>Change from baseline brain creatine at 3 months</time_frame>
      <description>Magnetic resonance spectra for brain creatine</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient-reported symptoms</measure>
      <time_frame>Change from baseline fatigue at 3 months</time_frame>
      <description>Scale of symptoms assessed by Visal Analog Scales (VAS)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time to exhaustion</measure>
      <time_frame>Change from baseline time to exhaustion at 3 months</time_frame>
      <description>Running time to exhaustion during incrementaltestontreadmill</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">52</enrollment>
    <condition>Long COVID</condition>
    <arm_group>
      <arm_group_label>Pre-probiotic</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>One sachet per day during breakfast</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>One sachet per day during breakfast</description>
    </arm_group>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>Dietary Supplement: Experimental</intervention_name>
      <description>Combination of pre-probiotic</description>
      <arm_group_label>Pre-probiotic</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>Dietary Supplement: Placebo</intervention_name>
      <description>Inert compound</description>
      <arm_group_label>Placebo</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age 18 - 65 years&#xD;
  &#xD;
            -  Covid-19 positive test within last 3 months (as documented byvalid PCR or antigentest&#xD;
  &#xD;
            -  Moderate-to-severe fatigue (20-MFI test total score &gt; 43.5)&#xD;
  &#xD;
            -  At least one of additional covid-19 related symptoms&#xD;
               (anosmia,ageusia,breathingdifficulties,lungpain, body aches, headaches, difficulties&#xD;
               concentrating etc.)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Other pulmonary and cardiovascular conditions&#xD;
  &#xD;
            -  History of dietary supplement use during the past 4 weeks&#xD;
  &#xD;
            -  Organic gastrointestinal (GI) disorders such as inflammatory bowel disease, coeliac&#xD;
               disease, eosinophilic disorders, or current infection of the GI tract.&#xD;
  &#xD;
            -  Bowel surgery or short bowel syndrome.&#xD;
  &#xD;
            -  Medication or supplement which can impact the gut microbiome, including: antibiotics,&#xD;
               antimicrobials, or antifungals in the two months&#xD;
  &#xD;
            -  Probiotic or prebiotic supplements in the last 4 weeks&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Applied Bioenergetics Lab at Faculty of Sport and PE</name>
        <address>
          <city>Novi Sad</city>
          <state>Vojvodina</state>
          <zip>21000</zip>
          <country>Serbia</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Serbia</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 25, 2023</study_first_submitted>
    <study_first_submitted_qc>August 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 28, 2023</study_first_posted>
    <last_update_submitted>August 25, 2023</last_update_submitted>
    <last_update_submitted_qc>August 25, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Novi Sad, Faculty of Sport and Physical Education</investigator_affiliation>
      <investigator_full_name>Sergej Ostojic</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <keyword>Prebiotic</keyword>
    <keyword>Probiotic</keyword>
    <keyword>Metabolism</keyword>
    <keyword>Fatigue</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Post-Acute COVID-19 Syndrome</mesh_term>
      <mesh_term>Fatigue</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>Data obtained through this study may be provided to qualified researchers with academic interest in long COVID. Data will be coded, with no PHI included. Approval of the request and execution of all applicable agreements are prerequisites to the sharing of data with the requesting party.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
      <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
      <ipd_time_frame>Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis.</ipd_time_frame>
    </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/NCT06013072
  org study id: 2022-03-23_CFS
  nct id: NCT06013072
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this randomized controlled double-blind parallel-group interventional trial is to
        evaluate the effects of of dietary supplementation with a pre-probiotic on patient- and
        clinician-reported outcomes, and brain tissue metabolism in patients with post-covid fatigue
        syndrome.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Supportive Care
  masking: Triple (Participant, Care Provider, Investigator)
  measure: Fatigue
  time frame: Change from baseline fatigue at 3 months
  description: Level of fatigue as assessed by the Multidimensional Fatigue Inventory (MFI)
  measure: Brain creatine
  time frame: Change from baseline brain creatine at 3 months
  description: Magnetic resonance spectra for brain creatine
  measure: Patient-reported symptoms
  time frame: Change from baseline fatigue at 3 months
  description: Scale of symptoms assessed by Visal Analog Scales (VAS)
  measure: Time to exhaustion
  time frame: Change from baseline time to exhaustion at 3 months
  description: Running time to exhaustion during incrementaltestontreadmill
  arm group label: Pre-probiotic
  arm group type: Experimental
  description: One sachet per day during breakfast
  arm group label: Placebo
  arm group type: Placebo Comparator
  description: One sachet per day during breakfast
  intervention type: Dietary Supplement
  intervention name: Dietary Supplement: Experimental
  description: Combination of pre-probiotic
  arm group label: Pre-probiotic
  intervention type: Dietary Supplement
  intervention name: Dietary Supplement: Placebo
  description: Inert compound
  arm group label: Placebo
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: No
  facility: 
  country: Serbia
  responsible party type: Principal Investigator
  investigator affiliation: University of Novi Sad, Faculty of Sport and Physical Education
  investigator full name: Sergej Ostojic
  investigator title: Professor
  mesh term: Post-Acute COVID-19 Syndrome
  mesh term: Fatigue
  sharing ipd: Yes
  ipd description: Data obtained through this study may be provided to qualified researchers with academic interest in long COVID. Data will be coded, with no PHI included. Approval of the request and execution of all applicable agreements are prerequisites to the sharing of data with the requesting party.
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Informed Consent Form (ICF)
  ipd info type: Clinical Study Report (CSR)
  ipd time frame: Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis.