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OpenTrials
Completed

NCT Number: NCT03794479

Intestinal Microbiota and Antimicrobial Resistance in Hong Kong Residents After Travel

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.

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Key information

Conditions

Antimicrobial Resistance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Prince of Wales Hospital

Shatin, Hong Kong

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Jan 7, 2019
Registry last updated
Aug 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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