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/NCT05972590</url>
    </required_header>
    <id_info>
      <org_study_id>2023-A00947-38</org_study_id>
      <nct_id>NCT05972590</nct_id>
    </id_info>
    <brief_title>Characterization of Fecal Microbiota in a Population Aged 50 to 75 Years Targeted by Seasonal Vaccination</brief_title>
    <acronym>FIFTY+</acronym>
    <official_title>Interventional, With Minimal Risks and Constraints Study Aiming at Constituting a Biological Samples Collection Constituted From Volunteers Aged Between 50 and 75 Years Old And Used For Scientific Purposes</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Bioaster</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>BioFortis</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Bioaster</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 interventional study is to constitute a biological samples collection&#xD;
        collected from healthy elderly volunteers and used for scientific purposes.&#xD;
  &#xD;
        The main questions it aims to answer are:&#xD;
  &#xD;
          -  Improving knowledge of the composition of the gut microbiota&#xD;
  &#xD;
          -  Identify, isolate and culture microbiota species of interest in the field of health&#xD;
             ageing or used as therapeutics associated to the vaccination&#xD;
  &#xD;
          -  Determining the correlation between the gut microbiota composition and the immune&#xD;
             response of individuals.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The compositional analysis of commensal bacterial populations collected from a variety of&#xD;
        clinical samples has been recently made possible with the availability of Next Generation&#xD;
        Sequencing (NGS) technologies. The term 'next-generation probiotics' (NGP) is now widely used&#xD;
        to describe these commensal species of potential health interest.&#xD;
  &#xD;
        However, this approach is still hampered by the fact that there are usually few or even no&#xD;
        strains available for a number of commensal species.&#xD;
  &#xD;
        In this context, BIOASTER has developed a specific technological process based on flow&#xD;
        cytometry analysis and then sorting under strictly anaerobic conditions to target and&#xD;
        cultivate commensal species of interest.&#xD;
  &#xD;
        The goal of this study is to constitute a biological samples collection from elderly people,&#xD;
        to proceed with the isolation of beneficial commensal strains such as Faecalibacterium&#xD;
        prausnitzii, Akkermansia muciniphila and Oscillospiraceae, in a non-limitative way.&#xD;
  &#xD;
        BIOASTER's objective is to strengthen technological support, provide new knowledges and tools&#xD;
        for the development of next-generation products. Numerous biotherapeutics companies will&#xD;
        benefit from this pipeline, ultimately improving the chances of survival in life-threatening&#xD;
        diseases with unmet medical needs.&#xD;
  &#xD;
        Elderly people will be recruited by the investigational unit Biofortis.&#xD;
  &#xD;
        Blood (Whole blood + TruCulture tubes) and feces will be collected from each volunteer.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">July 24, 2023</start_date>
    <completion_date type="Anticipated">December 15, 2023</completion_date>
    <primary_completion_date type="Anticipated">December 15, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Basic Science</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Number and ratio of participants with per protocol collection of blood and feces</measure>
      <time_frame>Baseline</time_frame>
      <description>Number of volunteers included in the study and number blood/feces pairs collected.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Total number of bacteria strains collected</measure>
      <time_frame>Baseline</time_frame>
      <description>Isolation and culture of bacteria of interest in anaerobic conditions: constitution of a biobank of Akkermansia muciniphila, Faecalibacterium prausnitzii and Oscillospiraceae) for research purposes.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Fecal microbiome richness as assessed by alpha diversity</measure>
      <time_frame>Baseline</time_frame>
      <description>Genus and species of bacteria contained in the intestinal microbiota (alpha diversity calculation)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Immunophenotyping of volunteers as assessed by cytokines quantification</measure>
      <time_frame>Baseline</time_frame>
      <description>serum samples will be analyzed by ELISA method to quantify cytokines</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Immunophenotyping of volunteers as assessed by flow cytometry on immune cells</measure>
      <time_frame>Baseline</time_frame>
      <description>peripheral blood mononuclear cells will be stained with specific markers antibodies to characterize immune cells populations</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Elderly Volunteers</condition>
    <arm_group>
      <arm_group_label>50-75 years old volunteers cohort</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>Biological samples collection Blood drawing + faeces collection</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Biological samples collection (blood + feces)</intervention_name>
      <description>Blood + stools samples will be collected from each volunteer</description>
      <arm_group_label>50-75 years old volunteers cohort</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Subjects aged between 50 and 75,&#xD;
  &#xD;
            -  BMI between 18.5 and 29 kg/m2,&#xD;
  &#xD;
            -  Normal clinical examination,&#xD;
  &#xD;
            -  Written consent obtained&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Diagnosed acute or chronic gastrointestinal disease or complication (e.g., celiac&#xD;
               disease, gastroesophageal reflux, gastric or duodenal ulcer, Crohn's disease,&#xD;
               hemorrhoids, irritable bowel syndrome)&#xD;
  &#xD;
            -  Infectious gastrointestinal event within 3 months prior to inclusion&#xD;
  &#xD;
            -  Severe chronic disease (active cancer, HIV, severe renal failure, ongoing severe heart&#xD;
               or liver or biliary disorders, arthritis) or severe chronic disease deemed&#xD;
               incompatible with the conduct of the study by the investigator&#xD;
  &#xD;
            -  Major surgical procedure likely to disrupt the intestinal microbiota, within 6 months&#xD;
               prior to inclusion&#xD;
  &#xD;
            -  Recent food allergy &lt; 3 months prior to inclusion&#xD;
  &#xD;
            -  Antibiotic, antiviral, antifungal, proton pump inhibitor or any other treatment likely&#xD;
               to disrupt the microbiota in the 3 months prior to inclusion&#xD;
  &#xD;
            -  Previous or current use of a treatment that may disrupt the microbiota (e.g.&#xD;
               laxatives, antidiarrheals, antacids...) in the last 3 months&#xD;
  &#xD;
            -  Significant change in dietary habits or physical activities in the 3 months prior to&#xD;
               inclusion&#xD;
  &#xD;
            -  Consumption of more than 2 standard glasses of alcoholic beverages per day&#xD;
  &#xD;
            -  Smoking &gt; 20 cigarettes per day, illicit drug use,&#xD;
  &#xD;
            -  Daily use of non-steroidal anti-inflammatory drugs (NSAIDs)&#xD;
  &#xD;
            -  Severe psychiatric or neurological pathology&#xD;
  &#xD;
            -  Subject with liquid stools (Bristol Score = 7) or very hard stools (Bristol Score = 1)&#xD;
  &#xD;
            -  Any vaccination in the last month before inclusion&#xD;
  &#xD;
            -  Subject unable to understand the purpose of the research, answer questions and give&#xD;
               their decision to participate in the study&#xD;
  &#xD;
            -  Subject already included in another research study involving the human subject&#xD;
  &#xD;
            -  Subject under guardianship and whose guardianship objects to the participation of&#xD;
               his/her protectee,&#xD;
  &#xD;
            -  Subject not affiliated with a social security plan or not a beneficiary of such a plan&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>50 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Cyril GUYARD</last_name>
      <role>Study Director</role>
      <affiliation>Bioaster</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Stéphanie CAVIGIOLI</last_name>
      <role>Principal Investigator</role>
      <affiliation>BioFortis</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Karen LOUIS</last_name>
      <phone>+33 6 34 45 23 34</phone>
      <email>karen.louis@bioaster.org</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Benoît LEVAST</last_name>
      <phone>+33 6 60 90 79 42</phone>
      <email>benoit.levast@bioaster.org</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Biofortis</name>
        <address>
          <city>Paris</city>
          <zip>75012</zip>
          <country>France</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Stéphanie CAVIGIOLI</last_name>
        <email>biofortis-uic-paris@biofortis.fr</email>
      </contact>
      <contact_backup>
        <last_name>Pierrick GUERIF</last_name>
        <email>biofortis-uic-paris@biofortis.fr</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>France</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 10, 2023</study_first_submitted>
    <study_first_submitted_qc>July 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 2, 2023</study_first_posted>
    <last_update_submitted>July 24, 2023</last_update_submitted>
    <last_update_submitted_qc>July 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 2, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Biobank</keyword>
    <keyword>Health Ageing</keyword>
    <keyword>Blood, TruCultures</keyword>
    <keyword>Stools</keyword>
    <keyword>Strain isolation</keyword>
    <keyword>Probiotics</keyword>
    <keyword>Immunity</keyword>
    <keyword>Vaccination</keyword>
    <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/NCT05972590
  org study id: 2023-A00947-38
  nct id: NCT05972590
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this interventional study is to constitute a biological samples collection
        collected from healthy elderly volunteers and used for scientific purposes.
  
        The main questions it aims to answer are:
  
          -  Improving knowledge of the composition of the gut microbiota
  
          -  Identify, isolate and culture microbiota species of interest in the field of health
             ageing or used as therapeutics associated to the vaccination
  
          -  Determining the correlation between the gut microbiota composition and the immune
             response of individuals.
  The compositional analysis of commensal bacterial populations collected from a variety of
        clinical samples has been recently made possible with the availability of Next Generation
        Sequencing (NGS) technologies. The term 'next-generation probiotics' (NGP) is now widely used
        to describe these commensal species of potential health interest.
  
        However, this approach is still hampered by the fact that there are usually few or even no
        strains available for a number of commensal species.
  
        In this context, BIOASTER has developed a specific technological process based on flow
        cytometry analysis and then sorting under strictly anaerobic conditions to target and
        cultivate commensal species of interest.
  
        The goal of this study is to constitute a biological samples collection from elderly people,
        to proceed with the isolation of beneficial commensal strains such as Faecalibacterium
        prausnitzii, Akkermansia muciniphila and Oscillospiraceae, in a non-limitative way.
  
        BIOASTER's objective is to strengthen technological support, provide new knowledges and tools
        for the development of next-generation products. Numerous biotherapeutics companies will
        benefit from this pipeline, ultimately improving the chances of survival in life-threatening
        diseases with unmet medical needs.
  
        Elderly people will be recruited by the investigational unit Biofortis.
  
        Blood (Whole blood + TruCulture tubes) and feces will be collected from each volunteer.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Basic Science
  masking: None (Open Label)
  measure: Number and ratio of participants with per protocol collection of blood and feces
  time frame: Baseline
  description: Number of volunteers included in the study and number blood/feces pairs collected.
  measure: Total number of bacteria strains collected
  time frame: Baseline
  description: Isolation and culture of bacteria of interest in anaerobic conditions: constitution of a biobank of Akkermansia muciniphila, Faecalibacterium prausnitzii and Oscillospiraceae) for research purposes.
  measure: Fecal microbiome richness as assessed by alpha diversity
  time frame: Baseline
  description: Genus and species of bacteria contained in the intestinal microbiota (alpha diversity calculation)
  measure: Immunophenotyping of volunteers as assessed by cytokines quantification
  time frame: Baseline
  description: serum samples will be analyzed by ELISA method to quantify cytokines
  measure: Immunophenotyping of volunteers as assessed by flow cytometry on immune cells
  time frame: Baseline
  description: peripheral blood mononuclear cells will be stained with specific markers antibodies to characterize immune cells populations
  arm group label: 50-75 years old volunteers cohort
  arm group type: Other
  description: Biological samples collection Blood drawing + faeces collection
  intervention type: Other
  intervention name: Biological samples collection (blood + feces)
  description: Blood + stools samples will be collected from each volunteer
  arm group label: 50-75 years old volunteers cohort
  criteria: 
  gender: All
  minimum age: 50 Years
  maximum age: 75 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Cyril GUYARD
  role: Study Director
  affiliation: Bioaster
  last name: Stéphanie CAVIGIOLI
  role: Principal Investigator
  affiliation: BioFortis
  last name: Karen LOUIS
  phone: +33 6 34 45 23 34
  email: karen.louis@bioaster.org
  last name: Benoît LEVAST
  phone: +33 6 60 90 79 42
  email: benoit.levast@bioaster.org
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: France
  responsible party type: Sponsor
  sharing ipd: No