Etiology of Travelers' Diarrhea in Australian Tourists Tr... | NCT06363890

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

NCT06363890

Sponsor

Lumen Bioscience, Inc.

Status

Recruiting

Last Update Posted

Sep 4, 2025Actual

Enrollment

1,200Estimated

Phase

Not provided

Conditions

Travelers Diarrhea

Interventions

TAQMan Array Card

Countries

Australia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 20, 2024Actual

Primary Completion Date

Mar 1, 2026Estimated

Completion Date

Jul 1, 2026Estimated

First Submitted Date

Apr 9, 2024

First Submission Date that Met QC Criteria

Apr 9, 2024

First Posted Date

Apr 12, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 2, 2025

Last Update Posted Date

Sep 4, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Adult Australian travelers		1200 Healthy Australian adult tourists traveling to Southeast Asia.	Diagnostic Test: TAQMan Array Card

Interventions

Name	Type	Description	Arm Group Labels	Other Names
TAQMan Array Card	Diagnostic Test	Real time PCR test to detect diarrheal pathogens.	Adult Australian travelers

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

1200 Australian adult tourists traveling to Southeast Asia

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Carl Mason, MD	Contact	2068991904		trials@lumen.bio
Asa Davis, MD	Contact	2068991904		trials@lumen.bio

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
AK Clinical Research	Recruiting	Melbourne			Australia