Intestinal Microbiota and Antimicrobial Resistance in Hong Kong Residents After Travel

NCT03794479 | Completed DMC

• 1 other identifier: travellers_version 2_20180724
• Study Type: observational
• Target: 125
• Locations: 1 country
• Sites: 1

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.

Conditions

Antimicrobial Resistance

Keywords

Intestinal microbiota; Antimicrobial resistance

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Proportion of patients acquiring intestinal colonization of carbapenem-resistant Enterobacteriaceae

  1 year

Study Arms (1)

Travellers

Adults planning for travel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults planning for travel

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Prince of Wales Hospital

Shatin, Hong Kong

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Stool sample retained.

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 3, 2019
• First Posted: January 7, 2019
• Study Start: November 5, 2018
• Primary Completion: June 6, 2023
• Study Completion: June 6, 2023
• Last Updated: August 30, 2023

Record last verified: 2023-08

Locations

HK (1)