Intestinal Microbiota and Antimicrobial Resistance in Hong Kong Residents After Travel

Sponsor

Chinese University of Hong Kong (Other)

Overall Status

Unknown status

CT.gov ID

NCT03794479

Collaborator

(none)

400

Enrollment

Location

39.8

Anticipated Duration (Months)

10.1

Patients Per Site Per Month

Study Details

Study Description

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	Intervention/Treatment	Phase
Antimicrobial Resistance

Study Design

Study Type:

Observational

Anticipated 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 :

Nov 5, 2018

Anticipated Primary Completion Date :

Aug 31, 2021

Anticipated Study Completion Date :

Feb 28, 2022

Arms and Interventions

Arm	Intervention/Treatment
Travellers Adults planning for travel

Outcome Measures

Primary Outcome Measures

Proportion of patients acquiring intestinal colonization of ESBL-producing Enterobacteriaceae [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

Proportion of patients acquiring intestinal colonization of carbapenem-resistant Enterobacteriaceae [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Prince of Wales Hospital	Sha Tin		Hong Kong

Sponsors and Collaborators

Chinese University of Hong Kong

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Grace Lui, Assistant Professor, Chinese University of Hong Kong

ClinicalTrials.gov Identifier:

NCT03794479

Other Study ID Numbers:

travellers_version 2_20180724

First Posted:

Jan 7, 2019

Last Update Posted:

Jan 7, 2019

Last Verified:

Jan 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Grace Lui, Assistant Professor, Chinese University of Hong Kong

Intestinal microbiota

Antimicrobial resistance

Study Results

No Results Posted as of Jan 7, 2019