Etiology of Travelers' Diarrhea in Australian Tourists Traveling to Southeast Asia (AusTD)

September 2, 2025 updated by: Lumen Bioscience, Inc.

Frequency and Etiology of Travelers' Diarrhea in Australian Adult Tourists Traveling to Southeast Asia

The study proposed here will determine the frequency and etiology of diarrhea in Australian adult tourists traveling to Southeast Asia, including Cambodia, Indonesia, Laos, Malaysia, Myanmar, the Philippines, Thailand, Timor-Leste, and Vietnam. The results from this study will inform the feasibility and design of subsequent clinical trials of travelers' diarrhea interventions in this population.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

1200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

1200 Australian adult tourists traveling to Southeast Asia

Description

Inclusion Criteria:

  • Adult aged > 18 years residing in Australia.
  • Planned travel for 14 to 28 days starting in the next 30 days to selected countries in Southeast Asia, including Cambodia, Indonesia, Laos, Malaysia, Myanmar, the Philippines, Thailand, Timor-Leste, and Vietnam.
  • Willing to participate in the clinical study and available for all planned study activities through approximately 28 days post-travel.
  • Access to a smartphone and mobile phone services while traveling (either by local SIM card, WiFi, or international roaming service on the individual's home-country mobile phone).

Exclusion Criteria:

  • Unable or unwilling to provide adequate informed consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Adult Australian travelers
1200 Healthy Australian adult tourists traveling to Southeast Asia.
Diagnostic test: TAQMan Array Card
Real time PCR test to detect diarrheal pathogens.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Characterize the frequency and etiology of travelers' diarrhea in this participant population of Australian adult tourists traveling to Southeast Asia.
Time Frame: 18 months

Incidence of new episodes of self-reported diarrhea per 100 person-months of travel in enrolled participants.

Among participants returning stool collection cards, compare the adjusted incidence of diarrhea attributed to specific etiologies.
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lumen Bioscience, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 20, 2024

Primary Completion (Estimated)

March 1, 2026

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

April 9, 2024

First Submitted That Met QC Criteria

April 9, 2024

First Posted (Actual)

April 12, 2024

Study Record Updates

Last Update Posted (Estimated)

September 4, 2025

Last Update Submitted That Met QC Criteria

September 2, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TD02

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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