<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/NCT03043300</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00092426</org_study_id>
    <secondary_id>16IPA1609428</secondary_id>
    <nct_id>NCT03043300</nct_id>
  </id_info>
  <brief_title>A Pilot Study Assessing Intestinal Microbiota Diversification and Changes After Travel to South(East) Asia From the US</brief_title>
  <acronym>ABROAD</acronym>
  <official_title>A Pilot Study to Assess the Intestinal MicroBiota Diversification States and Changes in U.S. Travelers After Return From Short-Term Travel to an Overseas South(East) Asian Destination</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Emory University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Centers for Disease Control and Prevention</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
  </sponsors>
  <source>Emory University</source>
  <oversight_info>
    <has_dmc>Yes</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 prospective, observational pilot study is designed to assess feasibility, refine the&#xD;
      target population, and quickly test qualitative and quantitative changes in the microbiome&#xD;
      after short-term travel to South or Southeast Asia, regions where rates of travelers'&#xD;
      diarrhea and intestinal colonization with antimicrobial resistant bacteria are highest.&#xD;
&#xD;
      To measure the diversity change of the intestinal microbiota, participants will complete a&#xD;
      questionnaire and provide a stool specimen at three different time points: prior to&#xD;
      traveling, two weeks after returning from traveling, and 14 weeks after returning from&#xD;
      traveling.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Travelers' diarrhea is the most common illness experienced by those going overseas. Estimates&#xD;
      vary, but incidence has been reported to range between 30-60%, depending on travel&#xD;
      destination and season. Multiple organisms have been implicated as causes of travelers'&#xD;
      diarrhea, but bacteria account for 80-90% of cases. There is mounting evidence that the&#xD;
      integrity of the intestinal microbiome may be a strong modulator of diarrheal disease, and&#xD;
      that intestinal infections and other factors, including stress, antibiotic exposure, and diet&#xD;
      may disrupt the diversity and overall composition of the microbiome. Dysbiosis, a state of&#xD;
      altered microbiota diversity, may be less resistant to the acquisition of intestinal&#xD;
      pathogens and colonization of multiple drug resistant organisms. Furthermore, disruptions in&#xD;
      the microbiome that may result from an episode of travelers' diarrhea may have a role in the&#xD;
      development of chronic diarrhea and post-infectious irritable bowel syndrome.&#xD;
&#xD;
      This prospective, observational pilot study is intended to obtain preliminary data to support&#xD;
      the rationale for a subsequent larger cohort study. This study is designed to assess&#xD;
      feasibility, refine the target population, and quickly test qualitative and quantitative&#xD;
      changes in the microbiome after short-term travel (seven to 21 days) to South or Southeast&#xD;
      Asia, regions where rates of travelers' diarrhea and intestinal colonization with&#xD;
      antimicrobial resistant bacteria are highest.&#xD;
&#xD;
      The target population will include 10 Emory University students and/or Emory University&#xD;
      Hospital TravelWell Clinic (TWC) patients who have international travel plans. Consented,&#xD;
      willing, and eligible participants will complete an initial eligibility screening, followed&#xD;
      by pre-travel, short-term post-travel, and long-term post-travel study visits. To determine&#xD;
      specific factors associated with diversity change of the intestinal microbiota and changes in&#xD;
      the presence of genes that code for antibiotic resistance, questionnaires designed to collect&#xD;
      data on demographics, medical history, diet, food intake, recent (within 12 weeks of&#xD;
      pre-travel assessment, during travel, or post-travel) illness history, medication use, travel&#xD;
      itinerary, travel activities, and relevant food and water risk behaviors will be completed at&#xD;
      each study visit. A stool sample will also be provided at each time point. Participants may&#xD;
      also choose to take part in an optional sub-study which involves banking leftover stool for&#xD;
      future research use.&#xD;
&#xD;
      The primary protocol objective is to pilot a study investigating the association between&#xD;
      travel and changes in the intestinal microbiome (including both bacterial and fungal&#xD;
      components) and the bacterial and fungal resistome.&#xD;
&#xD;
      The secondary protocol objective is to assess microbiota profile changes and reversion to or&#xD;
      toward the pre-travel state by comparing pre-travel stool specimen sequencing results to&#xD;
      short-term post-travel and long-term post-travel stool specimen sequencing results.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 7, 2017</start_date>
  <completion_date type="Actual">December 1, 2018</completion_date>
  <primary_completion_date type="Actual">December 1, 2018</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Predominant Intestinal Microbiota Genus or Strain</measure>
    <time_frame>Pre-travel to 14 Weeks Post-Travel</time_frame>
    <description>A genus of strain will be considered predominant if it represents at least 30% of all genus or strains of microbiota within the stool sample.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Alpha and Beta Diversity of Intestinal Microbiota</measure>
    <time_frame>Pre-travel to 14 Weeks Post-Travel</time_frame>
    <description>Maximum percentage of all genes identified included within the same taxon will be determined from each stool sample.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Firmicutes:Bacteroides Ratio of Microbiota</measure>
    <time_frame>Pre-travel to 14 Weeks Post-Travel</time_frame>
    <description>Firmicutes and Bacteroides are groups of bacteria present in the gut and the Firmicutes to Bacteroidetes ratio is considered a significant aspect of microbiota composition. The Firmicutes to Bacteroidetes ratio will be determined from each stool sample.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Enteropathogens of Stool Microbiota</measure>
    <time_frame>Pre-travel to 14 Weeks Post-Travel</time_frame>
    <description>The presence of enteropathogens in stool samples will be examined pre- and post-travel.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Stool Resistome</measure>
    <time_frame>Pre-travel to 14 Weeks Post-Travel</time_frame>
    <description>Review of the resistome will include a summary of the overall number and diversity of bacterial and fungal resistance genes including any new acquisition.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Reversion toward pre-travel microbiota state</measure>
    <time_frame>Pre-travel to 14 Weeks Post-Travel</time_frame>
    <description>Microbiota profile changes and reversion to or toward the pre-travel state will be assessed by comparing pre-travel stool specimen sequencing results to short-term post-travel and long-term post-travel stool specimen sequencing results.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">10</enrollment>
  <condition>Dysbiosis</condition>
  <arm_group>
    <arm_group_label>US Travelers to South or Southeast Asia</arm_group_label>
    <description>Adult individuals who are planning a short term trip to South or Southeast Asia and meet all eligibility criteria will complete the questionnaires and/or provide stool specimens at the following time points:&#xD;
No greater than 4 weeks prior to travel departure: Screening Criteria Review&#xD;
One week prior to travel departure: Pre-Travel Questionnaire and Pre-Travel Stool Specimen Collection&#xD;
Two weeks after return from travel: Short-Term Post-Travel Questionnaire and Short-Term Post-Travel Stool Specimen Collection&#xD;
14 weeks after return from travel: Long-Term Post-Travel Questionnaire and Long-Term Post-Travel Stool Specimen Collection</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Screening Criteria Review</intervention_name>
    <description>The screening criteria review is an 8 item instrument collecting information during screening about overall health, including self-reported chronic intestinal conditions, immunocompromising conditions, the use of certain medication types (immunosuppressives and antibiotics), and pregnancy status. The instrument will also collect dates of planned travel to South(east) as well as preferred dates for study visits and reminder contacts.&#xD;
This instrument will be administered verbally by the study team and completed no more than 4 weeks prior to travel departure from the United States.</description>
    <arm_group_label>US Travelers to South or Southeast Asia</arm_group_label>
    <other_name>Appendix A</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Pre-Travel Questionnaire</intervention_name>
    <description>The pre-travel questionnaire is a 29 item instrument collecting information about baseline characteristics, dietary habits, travel plans, and health history.&#xD;
This questionnaire will be administered verbally by the study team and completed 1 week prior to travel departure from the United States.</description>
    <arm_group_label>US Travelers to South or Southeast Asia</arm_group_label>
    <other_name>Appendix C</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Pre-Travel Stool Specimen Collection</intervention_name>
    <description>The pre-travel stool specimen collection will occur 1 week prior to travel departure from the United States.&#xD;
The processing and analyses of this stool specimen will be performed by the Centers for Disease Control and Prevention.</description>
    <arm_group_label>US Travelers to South or Southeast Asia</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Short-Term Post-Travel Questionnaire</intervention_name>
    <description>The short-term post-travel questionnaire is a 19 item instrument collecting information about dates and locations of travel, food and beverages consumed while traveling, and illnesses during or following traveling.&#xD;
This questionnaire will be administered verbally by the study team and completed 2 weeks after returning to the United States from travel.</description>
    <arm_group_label>US Travelers to South or Southeast Asia</arm_group_label>
    <other_name>Appendix D</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Short-Term Post-Travel Stool Specimen Collection</intervention_name>
    <description>The short-term post-travel stool specimen collection will occur 2 weeks after returning to the United States from travel.&#xD;
The processing and analyses of this stool specimen will be performed by the Centers for Disease Control and Prevention.</description>
    <arm_group_label>US Travelers to South or Southeast Asia</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Long-Term Post-Travel Questionnaire</intervention_name>
    <description>The long-term post-travel questionnaire is a 16 item instrument collecting information about illnesses since last study visit, dietary habits since last study visit, and any traveling since the last visit.&#xD;
This questionnaire will be administered verbally by the study team and completed 14 weeks after returning to the United States from travel.</description>
    <arm_group_label>US Travelers to South or Southeast Asia</arm_group_label>
    <other_name>Appendix E</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Long-Term Post-Travel Stool Specimen Collection</intervention_name>
    <description>The short-term post-travel stool specimen collection will occur 14 weeks after returning to the United States from travel.&#xD;
The processing and analyses of this stool specimen will be performed by the Centers for Disease Control and Prevention.</description>
    <arm_group_label>US Travelers to South or Southeast Asia</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Every stool specimen will be collected by the participant and placed in a kit and stored for&#xD;
      deoxyribonucleic acid (DNA) extraction and sequencing. Specimens will be batched for&#xD;
      analysis.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Emory University students and/or Emory University Hospital's TravelWell Center patients&#xD;
        with international travel plans&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Ability to understand and the willingness to sign a written informed consent document.&#xD;
&#xD;
          2. Ability and willingness to comply with study protocol requirements.&#xD;
&#xD;
          3. Completed screening criteria.&#xD;
&#xD;
          4. Departure date for international travel is planned for 4 weeks from the date of&#xD;
             informed consent.&#xD;
&#xD;
          5. Duration of international travel is planned for a minimum of seven days and maximum of&#xD;
             21 days.&#xD;
&#xD;
          6. International travel is planned to at least one of the following countries of&#xD;
             South(east) Asia:&#xD;
&#xD;
               1. South Asia, defined as: Afghanistan, Bangladesh, Bhutan, India, Maldives, Nepal,&#xD;
                  Pakistan, Sri Lanka&#xD;
&#xD;
               2. Southeast Asia, defined as: Cambodia, Laos, West Malaysia (excluding Malaysian&#xD;
                  Borneo), Myanmar (Burma), Thailand, Vietnam&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Women of childbearing potential who self-report to be either:&#xD;
&#xD;
               1. Currently pregnant&#xD;
&#xD;
               2. Planning a pregnancy during study participation&#xD;
&#xD;
          2. Current diarrhea (defined as ≥ 3 unformed loose stools in 24 hours)&#xD;
&#xD;
          3. Prior episode of diarrhea (defined as ≥ 3 unformed loose stools in 24 hours) in the 12&#xD;
             weeks prior to date of informed consent&#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>Colleen S Kraft, MD, MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>Emory University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Emory Univeristy Hospital Midtown, TravelWell Center</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30308</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Emory University</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30322</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>February 2, 2017</study_first_submitted>
  <study_first_submitted_qc>February 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 6, 2017</study_first_posted>
  <last_update_submitted>January 29, 2019</last_update_submitted>
  <last_update_submitted_qc>January 29, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 30, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Emory University</investigator_affiliation>
    <investigator_full_name>Colleen S Kraft, MD, MSc</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Travelers' diarrhea</keyword>
  <keyword>Intestinal microbiota</keyword>
  <keyword>Antibiotic resistance</keyword>
  <keyword>Antibiotics</keyword>
  <keyword>Gastrointestinal disorders</keyword>
  <keyword>Infectious diseases</keyword>
  <keyword>International Travel</keyword>
  <keyword>Travel Medicine</keyword>
  <keyword>Resistome</keyword>
  <keyword>Microbiome</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dysbiosis</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/NCT03043300
org study id: IRB00092426
secondary id: 16IPA1609428
nct id: NCT03043300
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This prospective, observational pilot study is designed to assess feasibility, refine the
      target population, and quickly test qualitative and quantitative changes in the microbiome
      after short-term travel to South or Southeast Asia, regions where rates of travelers'
      diarrhea and intestinal colonization with antimicrobial resistant bacteria are highest.

      To measure the diversity change of the intestinal microbiota, participants will complete a
      questionnaire and provide a stool specimen at three different time points: prior to
      traveling, two weeks after returning from traveling, and 14 weeks after returning from
      traveling.
Travelers' diarrhea is the most common illness experienced by those going overseas. Estimates
      vary, but incidence has been reported to range between 30-60%, depending on travel
      destination and season. Multiple organisms have been implicated as causes of travelers'
      diarrhea, but bacteria account for 80-90% of cases. There is mounting evidence that the
      integrity of the intestinal microbiome may be a strong modulator of diarrheal disease, and
      that intestinal infections and other factors, including stress, antibiotic exposure, and diet
      may disrupt the diversity and overall composition of the microbiome. Dysbiosis, a state of
      altered microbiota diversity, may be less resistant to the acquisition of intestinal
      pathogens and colonization of multiple drug resistant organisms. Furthermore, disruptions in
      the microbiome that may result from an episode of travelers' diarrhea may have a role in the
      development of chronic diarrhea and post-infectious irritable bowel syndrome.

      This prospective, observational pilot study is intended to obtain preliminary data to support
      the rationale for a subsequent larger cohort study. This study is designed to assess
      feasibility, refine the target population, and quickly test qualitative and quantitative
      changes in the microbiome after short-term travel (seven to 21 days) to South or Southeast
      Asia, regions where rates of travelers' diarrhea and intestinal colonization with
      antimicrobial resistant bacteria are highest.

      The target population will include 10 Emory University students and/or Emory University
      Hospital TravelWell Clinic (TWC) patients who have international travel plans. Consented,
      willing, and eligible participants will complete an initial eligibility screening, followed
      by pre-travel, short-term post-travel, and long-term post-travel study visits. To determine
      specific factors associated with diversity change of the intestinal microbiota and changes in
      the presence of genes that code for antibiotic resistance, questionnaires designed to collect
      data on demographics, medical history, diet, food intake, recent (within 12 weeks of
      pre-travel assessment, during travel, or post-travel) illness history, medication use, travel
      itinerary, travel activities, and relevant food and water risk behaviors will be completed at
      each study visit. A stool sample will also be provided at each time point. Participants may
      also choose to take part in an optional sub-study which involves banking leftover stool for
      future research use.

      The primary protocol objective is to pilot a study investigating the association between
      travel and changes in the intestinal microbiome (including both bacterial and fungal
      components) and the bacterial and fungal resistome.

      The secondary protocol objective is to assess microbiota profile changes and reversion to or
      toward the pre-travel state by comparing pre-travel stool specimen sequencing results to
      short-term post-travel and long-term post-travel stool specimen sequencing results.
observational model: Other
time perspective: Prospective
measure: Change in Predominant Intestinal Microbiota Genus or Strain
time frame: Pre-travel to 14 Weeks Post-Travel
description: A genus of strain will be considered predominant if it represents at least 30% of all genus or strains of microbiota within the stool sample.
measure: Change in Alpha and Beta Diversity of Intestinal Microbiota
time frame: Pre-travel to 14 Weeks Post-Travel
description: Maximum percentage of all genes identified included within the same taxon will be determined from each stool sample.
measure: Change in Firmicutes:Bacteroides Ratio of Microbiota
time frame: Pre-travel to 14 Weeks Post-Travel
description: Firmicutes and Bacteroides are groups of bacteria present in the gut and the Firmicutes to Bacteroidetes ratio is considered a significant aspect of microbiota composition. The Firmicutes to Bacteroidetes ratio will be determined from each stool sample.
measure: Change in Enteropathogens of Stool Microbiota
time frame: Pre-travel to 14 Weeks Post-Travel
description: The presence of enteropathogens in stool samples will be examined pre- and post-travel.
measure: Change in Stool Resistome
time frame: Pre-travel to 14 Weeks Post-Travel
description: Review of the resistome will include a summary of the overall number and diversity of bacterial and fungal resistance genes including any new acquisition.
measure: Reversion toward pre-travel microbiota state
time frame: Pre-travel to 14 Weeks Post-Travel
description: Microbiota profile changes and reversion to or toward the pre-travel state will be assessed by comparing pre-travel stool specimen sequencing results to short-term post-travel and long-term post-travel stool specimen sequencing results.
arm group label: US Travelers to South or Southeast Asia
description: Adult individuals who are planning a short term trip to South or Southeast Asia and meet all eligibility criteria will complete the questionnaires and/or provide stool specimens at the following time points:
No greater than 4 weeks prior to travel departure: Screening Criteria Review
One week prior to travel departure: Pre-Travel Questionnaire and Pre-Travel Stool Specimen Collection
Two weeks after return from travel: Short-Term Post-Travel Questionnaire and Short-Term Post-Travel Stool Specimen Collection
14 weeks after return from travel: Long-Term Post-Travel Questionnaire and Long-Term Post-Travel Stool Specimen Collection
intervention type: Other
intervention name: Screening Criteria Review
description: The screening criteria review is an 8 item instrument collecting information during screening about overall health, including self-reported chronic intestinal conditions, immunocompromising conditions, the use of certain medication types (immunosuppressives and antibiotics), and pregnancy status. The instrument will also collect dates of planned travel to South(east) as well as preferred dates for study visits and reminder contacts.
This instrument will be administered verbally by the study team and completed no more than 4 weeks prior to travel departure from the United States.
arm group label: US Travelers to South or Southeast Asia
other name: Appendix A
intervention type: Other
intervention name: Pre-Travel Questionnaire
description: The pre-travel questionnaire is a 29 item instrument collecting information about baseline characteristics, dietary habits, travel plans, and health history.
This questionnaire will be administered verbally by the study team and completed 1 week prior to travel departure from the United States.
arm group label: US Travelers to South or Southeast Asia
other name: Appendix C
intervention type: Other
intervention name: Pre-Travel Stool Specimen Collection
description: The pre-travel stool specimen collection will occur 1 week prior to travel departure from the United States.
The processing and analyses of this stool specimen will be performed by the Centers for Disease Control and Prevention.
arm group label: US Travelers to South or Southeast Asia
intervention type: Other
intervention name: Short-Term Post-Travel Questionnaire
description: The short-term post-travel questionnaire is a 19 item instrument collecting information about dates and locations of travel, food and beverages consumed while traveling, and illnesses during or following traveling.
This questionnaire will be administered verbally by the study team and completed 2 weeks after returning to the United States from travel.
arm group label: US Travelers to South or Southeast Asia
other name: Appendix D
intervention type: Other
intervention name: Short-Term Post-Travel Stool Specimen Collection
description: The short-term post-travel stool specimen collection will occur 2 weeks after returning to the United States from travel.
The processing and analyses of this stool specimen will be performed by the Centers for Disease Control and Prevention.
arm group label: US Travelers to South or Southeast Asia
intervention type: Other
intervention name: Long-Term Post-Travel Questionnaire
description: The long-term post-travel questionnaire is a 16 item instrument collecting information about illnesses since last study visit, dietary habits since last study visit, and any traveling since the last visit.
This questionnaire will be administered verbally by the study team and completed 14 weeks after returning to the United States from travel.
arm group label: US Travelers to South or Southeast Asia
other name: Appendix E
intervention type: Other
intervention name: Long-Term Post-Travel Stool Specimen Collection
description: The short-term post-travel stool specimen collection will occur 14 weeks after returning to the United States from travel.
The processing and analyses of this stool specimen will be performed by the Centers for Disease Control and Prevention.
arm group label: US Travelers to South or Southeast Asia
Every stool specimen will be collected by the participant and placed in a kit and stored for
      deoxyribonucleic acid (DNA) extraction and sequencing. Specimens will be batched for
      analysis.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Colleen S Kraft, MD, MSc
role: Principal Investigator
affiliation: Emory University
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Emory University
investigator full name: Colleen S Kraft, MD, MSc
investigator title: Associate Professor
mesh term: Dysbiosis
sharing ipd: No