Intestinal Microbiota and Antimicrobial Resistance in Hong Kong Residents After Travel

Completed

• Conditions: Antimicrobial Resistance

• Registration Number: NCT03794479
• Lead Sponsor: 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, the investigators can delineate a potential causal relationship between host intestinal microbiota and subsequent risk of acquisition of multidrug-resistant organisms.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-11-05
• Study First Submitted: 2019-01-03
• Study First Submitted QC: 2019-01-03
• Study First Posted: 2019-01-07
• Primary Completion: 2023-06-06
• Study Completion: 2023-06-06
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-28
• Last Update Posted: 2023-08-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 125

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Prince of Wales Hospital; 🇭🇰 Sha Tin, Hong Kong