## Protocol Section
### Identification Module
**NCT ID:** NCT03794479

**Brief Title:** Intestinal Microbiota and Antimicrobial Resistance in Hong Kong Residents After Travel

**Official Title:** Changes in Intestinal Microbiota and Acquisition of Antimicrobial Resistance in Hong Kong Residents After Travel

#### Organization Study ID Info
**ID:** travellers_version 2_20180724
#### Organization
**Class:** OTHER
**Full Name:** Chinese University of Hong Kong
### Status Module
#### Completion Date
**Date:** 2023-06-06

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-08-30

**Type:** ACTUAL

**Last Update Submit Date:** 2023-08-28

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2023-06-06

**Type:** ACTUAL

#### Start Date
**Date:** 2018-11-05

**Type:** ACTUAL

**Status Verified Date:** 2023-08

#### Study First Post Date
**Date:** 2019-01-07
**Type:** ACTUAL
**Study First Submit Date:** 2019-01-03
**Study First Submit QC Date:** 2019-01-03
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Chinese University of Hong Kong

#### Responsible Party

**Investigator Affiliation:** Chinese University of Hong Kong

**Investigator Full Name:** Grace Lui

**Investigator Title:** Assistant Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**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 Module

**Conditions:**

- Antimicrobial Resistance

**Keywords:**

- Intestinal microbiota

- Antimicrobial resistance

### Design Module

#### Bio Spec

**Description:** Stool sample retained.

**Retention:** SAMPLES_WITHOUT_DNA

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 125

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Adults planning for travel

**Label:** Travellers

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** Proportion of patients acquiring intestinal colonization of ESBL-producing Enterobacteriaceae

**Time Frame:** 1 year

#### Secondary Outcomes

**Description:** 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.

**Measure:** Proportion of patients acquiring intestinal colonization of carbapenem-resistant Enterobacteriaceae

**Time Frame:** 1 year

### Eligibility Module

**Eligibility Criteria:** 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

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** Adults planning for travel

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Sha Tin

**Country:** Hong Kong

**Facility:** Prince of Wales Hospital

### IPD Sharing Statement Module

**IPD Sharing:** UNDECIDED

## Derived Section

### Intervention Browse Module - Browse Branches

- Abbrev: Infe

- Name: Anti-Infective Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M4222

- Name: Anti-Bacterial Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4214

- Name: Anti-Infective Agents

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
