<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/NCT03282708</url>
  </required_header>
  <id_info>
    <org_study_id>2016-081</org_study_id>
    <secondary_id>ID-RCB: 2017-A00734-49</secondary_id>
    <nct_id>NCT03282708</nct_id>
  </id_info>
  <brief_title>Comparative Study of Great Ape-caretaker Microbiome</brief_title>
  <acronym>SHAPES-CAP</acronym>
  <official_title>Comparative Study of Captive Great Ape and Human Intestinal Microbiomes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Institut Pasteur</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Institut Pasteur</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 SHAPES-Captivity study seeks to identify metagenomic components of the intestinal&#xD;
      microbiome shared by human beings and captive great apes living in proximity and in direct,&#xD;
      daily contact. The investigators will determine the phylogenetic diversity of enterotypes&#xD;
      (bacterial and viral) shared between human beings and great apes and will link these results&#xD;
      with participant-observations of caretakers' activities (and contacts) with these great apes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The SHAPES-Captivity study seeks to identify metagenomic components of the intestinal&#xD;
      microbiome shared by human beings and captive great apes living in proximity and in direct,&#xD;
      daily contact. The SHAPES-Captivity is an extension of the SHAPES study (financed by the ANR&#xD;
      in 2014), currently ongoing in central Africa (Democratic Republic of Congo, Cameroon,&#xD;
      Gabon). In Cameroon, the investigators have collected stool samples from gorillas,&#xD;
      chimpanzees and human beings using the same forest space so as to conduct an analysis of the&#xD;
      overlap of their intestinal microbiome. The results of this analysis will be interpreted in&#xD;
      light of anthropological and geographical evidence collected among people living in this&#xD;
      region. SHAPES-Captivity will enable the investigators to use the same approach but this&#xD;
      time, under conditions of great ape captivity. The investigators will thus obtain data&#xD;
      concerning intestinal microbiome overlap between captive great apes and human caretakers&#xD;
      working in a controlled environment and in daily, direct contact. The SHAPES-Captivity study&#xD;
      will provide a positive control, which will eventually be compared to results from the SHAPES&#xD;
      study. Although multiple studies have investigated the overlap between human-great ape&#xD;
      intestinal microbiome (Moeller et al. 2012 ; Moeller et al. 2016), none of these studies have&#xD;
      investigated people living in close proximity to great apes, either in a natural or captive&#xD;
      setting. The investigators will determine the phylogenetic diversity of enterotypes&#xD;
      (bacterial and viral) shared between human beings and great apes, and will link these results&#xD;
      with their participant-observations of caretakers' activities (and contacts) with these great&#xD;
      apes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 6, 2017</start_date>
  <completion_date type="Actual">November 15, 2017</completion_date>
  <primary_completion_date type="Actual">November 15, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>1 group of caretakers (9 volunteers). For this group: one sample collection of spontaneously produced fresh stools (of the approximate size of 3 green beans);&#xD;
1 group of caretakers (8 volunteers). For this group: no intervention (participant-observation only)</intervention_model_description>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Microbiome comparison</measure>
    <time_frame>Three years (September 2017-September 2020)</time_frame>
    <description>The investigators will evaluate the components of the intestinal microbiome (viral and bacterial enterotypes) shared by human caretakers and captive great apes living in proximity on a daily basis. The percentage of overlap (of viral and bacterial families) between human subjects and great apes will be measured.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Contact type investigation</measure>
    <time_frame>Three years (September 2017-September 2020)</time_frame>
    <description>The investigators will evaluate the type of physical contact between caretakers and great apes in captivity through participant-observations. This outcome will be measured through identified categories of physical contact.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Contact frequency investigation</measure>
    <time_frame>Three years (September 2017-September 2020)</time_frame>
    <description>The investigators will evaluate the frequency of physical contact between caretakers and great apes in captivity through participant-observations. This outcome will be measured by the number per category of physical contact.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Contact duration investigation</measure>
    <time_frame>Three years (September 2017-September 2020)</time_frame>
    <description>The investigators will evaluate the duration of physical contact between caretakers and great apes in captivity through participant-observations. This outcome will be measured by the duration (time) per individual contact.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">14</enrollment>
  <condition>Human Intestinal Microbiome</condition>
  <arm_group>
    <arm_group_label>Microbiome</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Caretakers of captive great apes. One sample collection of spontaneously produced fresh stool (of an approximate size of 3 green beans).&#xD;
Data collection with self-administered questionnaire</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Anthropology</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Caretakers of captive great apes. Two four-hour participant-observations of each caretaker's activities with captive great apes</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Fresh stool collection</intervention_name>
    <description>One sample collection of spontaneously produced fresh stool (of an approximate size of 3 green beans).&#xD;
Data collection with self-administered questionnaire</description>
    <arm_group_label>Microbiome</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  For both Microbiome and Anthropology sub-study&#xD;
&#xD;
               -  Adult in good health&#xD;
&#xD;
               -  Currently working as a caretakers of captive great apes&#xD;
&#xD;
          -  For Microbiome sub-study&#xD;
&#xD;
               -  Agree to autonomous collection of a stool sample&#xD;
&#xD;
               -  Agree to return the stool specimen inside of a designated, supplied postal&#xD;
                  container and box.&#xD;
&#xD;
          -  For Anthropology sub-study:&#xD;
&#xD;
               -  Accept to be observed during his or her professional activity two times, each&#xD;
                  time for a duration of four hours by the researchers&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  For both Microbiome and Anthropology parts:&#xD;
&#xD;
               -  Protected adults, pregnant and nursing mothers will not be included.&#xD;
&#xD;
          -  For Microbiome sub-study&#xD;
&#xD;
               -  Patients, especially those with gastrointestinal disorders (diarrhea), frequent&#xD;
                  and/or liquid stools, abdominal pain, nausea, vomiting, fever&#xD;
&#xD;
               -  Anyone diagnosed with a chronic disease&#xD;
&#xD;
               -  Anyone who has taken an antibiotic or antifungal treatment in the month preceding&#xD;
                  collection.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tamara Giles-Vernick, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Institut Pasteur</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Institut Pasteur</name>
      <address>
        <city>Paris</city>
        <zip>75724</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>August 2, 2017</study_first_submitted>
  <study_first_submitted_qc>September 13, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 14, 2017</study_first_posted>
  <last_update_submitted>April 27, 2018</last_update_submitted>
  <last_update_submitted_qc>April 27, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 30, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>intestinal microbiome</keyword>
  <keyword>captive great apes</keyword>
  <keyword>human beings</keyword>
  <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/NCT03282708
org study id: 2016-081
secondary id: ID-RCB: 2017-A00734-49
nct id: NCT03282708
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The SHAPES-Captivity study seeks to identify metagenomic components of the intestinal
      microbiome shared by human beings and captive great apes living in proximity and in direct,
      daily contact. The investigators will determine the phylogenetic diversity of enterotypes
      (bacterial and viral) shared between human beings and great apes and will link these results
      with participant-observations of caretakers' activities (and contacts) with these great apes.
The SHAPES-Captivity study seeks to identify metagenomic components of the intestinal
      microbiome shared by human beings and captive great apes living in proximity and in direct,
      daily contact. The SHAPES-Captivity is an extension of the SHAPES study (financed by the ANR
      in 2014), currently ongoing in central Africa (Democratic Republic of Congo, Cameroon,
      Gabon). In Cameroon, the investigators have collected stool samples from gorillas,
      chimpanzees and human beings using the same forest space so as to conduct an analysis of the
      overlap of their intestinal microbiome. The results of this analysis will be interpreted in
      light of anthropological and geographical evidence collected among people living in this
      region. SHAPES-Captivity will enable the investigators to use the same approach but this
      time, under conditions of great ape captivity. The investigators will thus obtain data
      concerning intestinal microbiome overlap between captive great apes and human caretakers
      working in a controlled environment and in daily, direct contact. The SHAPES-Captivity study
      will provide a positive control, which will eventually be compared to results from the SHAPES
      study. Although multiple studies have investigated the overlap between human-great ape
      intestinal microbiome (Moeller et al. 2012 ; Moeller et al. 2016), none of these studies have
      investigated people living in close proximity to great apes, either in a natural or captive
      setting. The investigators will determine the phylogenetic diversity of enterotypes
      (bacterial and viral) shared between human beings and great apes, and will link these results
      with their participant-observations of caretakers' activities (and contacts) with these great
      apes.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: 1 group of caretakers (9 volunteers). For this group: one sample collection of spontaneously produced fresh stools (of the approximate size of 3 green beans);
1 group of caretakers (8 volunteers). For this group: no intervention (participant-observation only)
primary purpose: Basic Science
masking: None (Open Label)
measure: Microbiome comparison
time frame: Three years (September 2017-September 2020)
description: The investigators will evaluate the components of the intestinal microbiome (viral and bacterial enterotypes) shared by human caretakers and captive great apes living in proximity on a daily basis. The percentage of overlap (of viral and bacterial families) between human subjects and great apes will be measured.
measure: Contact type investigation
time frame: Three years (September 2017-September 2020)
description: The investigators will evaluate the type of physical contact between caretakers and great apes in captivity through participant-observations. This outcome will be measured through identified categories of physical contact.
measure: Contact frequency investigation
time frame: Three years (September 2017-September 2020)
description: The investigators will evaluate the frequency of physical contact between caretakers and great apes in captivity through participant-observations. This outcome will be measured by the number per category of physical contact.
measure: Contact duration investigation
time frame: Three years (September 2017-September 2020)
description: The investigators will evaluate the duration of physical contact between caretakers and great apes in captivity through participant-observations. This outcome will be measured by the duration (time) per individual contact.
arm group label: Microbiome
arm group type: Experimental
description: Caretakers of captive great apes. One sample collection of spontaneously produced fresh stool (of an approximate size of 3 green beans).
Data collection with self-administered questionnaire
arm group label: Anthropology
arm group type: No Intervention
description: Caretakers of captive great apes. Two four-hour participant-observations of each caretaker's activities with captive great apes
intervention type: Other
intervention name: Fresh stool collection
description: One sample collection of spontaneously produced fresh stool (of an approximate size of 3 green beans).
Data collection with self-administered questionnaire
arm group label: Microbiome
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Tamara Giles-Vernick, PhD
role: Study Director
affiliation: Institut Pasteur
facility: 
country: France
responsible party type: Sponsor
sharing ipd: No