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

Recruiting

• Conditions: Travelers Diarrhea
• Interventions: Diagnostic Test: TAQMan Array Card

• Registration Number: NCT06363890
• Lead Sponsor: Lumen Bioscience, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-04-09
• Study First Submitted QC: 2024-04-09
• Study First Posted: 2024-04-12
• Study Start: 2024-06-20
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-09
• Last Update Posted: 2024-08-13
• Primary Completion: 2025-10-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1200

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Adult Australian travelers	TAQMan Array Card	1200 Healthy Australian adult tourists traveling to Southeast Asia.

Primary Outcome Measures

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

Trial Locations

Locations (1)

AK Clinical Research; 🇦🇺 Melbourne, Australia