Intestinal Microbiota and Antimicrobial Resistance in Hong Kong Residents After Travel

Antimicrobial Resistance Clinical Trial

Official title:

Changes in Intestinal Microbiota and Acquisition of Antimicrobial Resistance in Hong Kong Residents After Travel

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03794479
• Other study ID #: travellers_version 2_20180724
• Status: Completed
• Start date: November 5, 2018
• Est. completion date: June 6, 2023

Study information

• Verified date: August 2023
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: June 6, 2023
• Est. primary completion date: June 6, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Antimicrobial Resistance

Locations

Country	Name	City	State
Hong Kong	Prince of Wales Hospital	Sha Tin

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients acquiring intestinal colonization of ESBL-producing Enterobacteriaceae	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.	1 year
Secondary	Proportion of patients acquiring intestinal colonization of carbapenem-resistant Enterobacteriaceae	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.	1 year