<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/NCT03794479</url>
  </required_header>
  <id_info>
    <org_study_id>travellers_version 2_20180724</org_study_id>
    <nct_id>NCT03794479</nct_id>
  </id_info>
  <brief_title>Intestinal Microbiota and Antimicrobial Resistance in Hong Kong Residents After Travel</brief_title>
  <official_title>Changes in Intestinal Microbiota and Acquisition of Antimicrobial Resistance in Hong Kong Residents After Travel</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chinese University of Hong Kong</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chinese University of Hong Kong</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>
      International travel is well reported to be associated with acquisition of&#xD;
      multidrug-resistant organisms, however, the impact of colonization of these&#xD;
      multidrug-resistant organisms is currently uncertain. As colonization of multidrug-resistant&#xD;
      organisms had been demonstrated to be associated with distinct intestinal microbiota&#xD;
      composition and travellers constitute a generally healthy population with minimal antibiotics&#xD;
      exposure; by evaluating serial stool samples before and after travel, the investigators can&#xD;
      delineate a potential causal relationship between host intestinal microbiota and subsequent&#xD;
      risk of acquisition of multidrug-resistant organisms.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 5, 2018</start_date>
  <completion_date type="Actual">June 6, 2023</completion_date>
  <primary_completion_date type="Actual">June 6, 2023</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Proportion of patients acquiring intestinal colonization of ESBL-producing Enterobacteriaceae</measure>
    <time_frame>1 year</time_frame>
    <description>Intestinal colonization of ESBL-producing Enterobacteriaceae is defined as the presence of ESBL in Enterobacteriaceae identified in the post-travel stool samples, in patients without these organisms detected in their stool samples before travel.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients acquiring intestinal colonization of carbapenem-resistant Enterobacteriaceae</measure>
    <time_frame>1 year</time_frame>
    <description>Intestinal colonization of carbapenem-resistant Enterobacteriaceae is defined as the presence of carbapenem-resistant Enterobacteriaceae identified in the stool samples, in patients without these organisms detected in their stool samples before travel.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">125</enrollment>
  <condition>Antimicrobial Resistance</condition>
  <arm_group>
    <arm_group_label>Travellers</arm_group_label>
    <description>Adults planning for travel</description>
  </arm_group>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Stool sample retained.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Adults planning for travel&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults aged 18 years or above&#xD;
&#xD;
          -  Chinese ethnicity&#xD;
&#xD;
          -  Planning to visit any places outside of Hong Kong within the next three months&#xD;
&#xD;
          -  Able to provide informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Use of antibiotics within 4 weeks prior to the time of recruitment (Except for&#xD;
             antimalarial prophylaxis)&#xD;
&#xD;
          -  Hospitalization within 3 months&#xD;
&#xD;
          -  Underlying gastrointestinal diseases, including gastrointestinal malignancy,&#xD;
             inflammatory bowel disease, resection of small or large bowel&#xD;
&#xD;
          -  Pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Prince of Wales Hospital</name>
      <address>
        <city>Sha Tin</city>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Hong Kong</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>January 3, 2019</study_first_submitted>
  <study_first_submitted_qc>January 3, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 7, 2019</study_first_posted>
  <last_update_submitted>August 28, 2023</last_update_submitted>
  <last_update_submitted_qc>August 28, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 30, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chinese University of Hong Kong</investigator_affiliation>
    <investigator_full_name>Grace Lui</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Intestinal microbiota</keyword>
  <keyword>Antimicrobial resistance</keyword>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03794479
org study id: travellers_version 2_20180724
nct id: NCT03794479
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
International travel is well reported to be associated with acquisition of
      multidrug-resistant organisms, however, the impact of colonization of these
      multidrug-resistant organisms is currently uncertain. As colonization of multidrug-resistant
      organisms had been demonstrated to be associated with distinct intestinal microbiota
      composition and travellers constitute a generally healthy population with minimal antibiotics
      exposure; by evaluating serial stool samples before and after travel, the investigators can
      delineate a potential causal relationship between host intestinal microbiota and subsequent
      risk of acquisition of multidrug-resistant organisms.
observational model: Cohort
time perspective: Prospective
measure: Proportion of patients acquiring intestinal colonization of ESBL-producing Enterobacteriaceae
time frame: 1 year
description: Intestinal colonization of ESBL-producing Enterobacteriaceae is defined as the presence of ESBL in Enterobacteriaceae identified in the post-travel stool samples, in patients without these organisms detected in their stool samples before travel.
measure: Proportion of patients acquiring intestinal colonization of carbapenem-resistant Enterobacteriaceae
time frame: 1 year
description: Intestinal colonization of carbapenem-resistant Enterobacteriaceae is defined as the presence of carbapenem-resistant Enterobacteriaceae identified in the stool samples, in patients without these organisms detected in their stool samples before travel.
arm group label: Travellers
description: Adults planning for travel
Stool sample retained.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Hong Kong
responsible party type: Principal Investigator
investigator affiliation: Chinese University of Hong Kong
investigator full name: Grace Lui
investigator title: Assistant Professor
sharing ipd: Undecided