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Intestinal Microbiota and Antimicrobial Resistance in Hong Kong Residents After Travel

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ClinicalTrials.gov Identifier: NCT03794479
Recruitment Status : Recruiting
First Posted : January 7, 2019
Last Update Posted : January 7, 2019
Sponsor:
Information provided by (Responsible Party):
Grace Lui, Chinese University of Hong Kong

Brief Summary:
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, we can delineate a potential causal relationship between host intestinal microbiota and subsequent risk of acquisition of multidrug-resistant organisms.

Condition or disease
Antimicrobial Resistance

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Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Changes in Intestinal Microbiota and Acquisition of Antimicrobial Resistance in Hong Kong Residents After Travel
Actual Study Start Date : November 5, 2018
Estimated Primary Completion Date : August 31, 2021
Estimated Study Completion Date : February 28, 2022

Resource links provided by the National Library of Medicine


Group/Cohort
Travellers
Adults planning for travel



Primary Outcome Measures :
  1. Proportion of patients acquiring intestinal colonization of ESBL-producing Enterobacteriaceae [ Time Frame: 1 year ]
    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.


Secondary Outcome Measures :
  1. Proportion of patients acquiring intestinal colonization of carbapenem-resistant Enterobacteriaceae [ Time Frame: 1 year ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adults planning for travel
Criteria

Inclusion Criteria:

  • Adults aged 18 years or above
  • Chinese ethnicity
  • Planning to visit any places outside of Hong Kong within the next three months
  • Able to provide informed consent

Exclusion Criteria:

  • Use of antibiotics within 4 weeks prior to the time of recruitment (Except for antimalarial prophylaxis)
  • Hospitalization within 3 months
  • Underlying gastrointestinal diseases, including gastrointestinal malignancy, inflammatory bowel disease, resection of small or large bowel
  • Pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03794479


Locations
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Hong Kong
Prince of Wales Hospital Recruiting
Sha Tin, Hong Kong
Contact: Grace Lui    35053376    gracelui@cuhk.edu.hk   
Contact: Rity Wong    35053376    ritywong@cuhk.edu.hk   
Sponsors and Collaborators
Chinese University of Hong Kong

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Responsible Party: Grace Lui, Assistant Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT03794479     History of Changes
Other Study ID Numbers: travellers_version 2_20180724
First Posted: January 7, 2019    Key Record Dates
Last Update Posted: January 7, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Grace Lui, Chinese University of Hong Kong:
Intestinal microbiota
Antimicrobial resistance

Additional relevant MeSH terms:
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Anti-Infective Agents
Anti-Bacterial Agents