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

NCT06363890 | Recruiting

• 1 other identifier: TD02
• Study Type: observational
• Target: 1,200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Travelers Diarrhea

Keywords

travelers diarrhea; australian; epidemiology

Outcome Measures

Primary Outcomes (1)

• Characterize the frequency and etiology of travelers' diarrhea in this participant population of Australian adult tourists traveling to Southeast Asia.

  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

Study Arms (1)

Adult Australian travelers

1200 Healthy Australian adult tourists traveling to Southeast Asia.

Diagnostic Test: TAQMan Array Card

Interventions

TAQMan Array Card DIAGNOSTIC_TEST

Real time PCR test to detect diarrheal pathogens.

Adult Australian travelers

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

1200 Australian adult tourists traveling to Southeast Asia

You may qualify if:

• 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).

You may not qualify if:

• Unable or unwilling to provide adequate informed consent.

Sponsors & Collaborators

• Lumen Bioscience, Inc.: lead

Study Sites (1)

AK Clinical Research

Melbourne, Australia

RECRUITING

Central Study Contacts

Carl Mason, MD

CONTACT

2068991904; trials@lumen.bio

Asa Davis, MD

CONTACT

2068991904; trials@lumen.bio

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2024
• First Posted: April 12, 2024
• Study Start: June 20, 2024
• Primary Completion: March 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: September 4, 2025

Record last verified: 2025-09

Locations

AU (1)