Travelers DiarrheaAusTDNCT06363890
Etiology of Travelers' Diarrhea in Australian Tourists Traveling to Southeast Asia
An observational study of Travelers Diarrhea, run by Lumen Bioscience, Inc. at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Travelers Diarrhea
- What is being tested?
- TAQMan Array Card
- How many people
- 2,400 participants
- Where
- 1 siteAustralia
- Study dates
- 20 Jun 2024to 1 Jul 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 1200 Australian adult tourists traveling to Southeast Asia
Who may be able to join
- 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).
Who cannot join
- Unable or unwilling to provide adequate informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Travelers Diarrhea
- Being tested
- TAQMan Array Card
- Keywords
- travelers diarrhea, australian, epidemiology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAQMan Array CardDiagnostic test
Real time PCR test to detect diarrheal pathogens.
| Study group | Role | What they receive |
|---|---|---|
| Adult Australian travelers | 1200 Healthy Australian adult tourists traveling to Southeast Asia. Receives: Diagnostic Test: TAQMan Array Card |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2024
- Study start20 Jun 2024
- Primary completion1 Mar 2026
- Study completion1 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Travelers DiarrheaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 2,400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lumen Bioscience, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06363890
- Sponsor's protocol ID
- TD02
- Acronym
- AusTD
- Status last verified
- Jul 2026
- First submitted
- 9 Apr 2024
- Last updated
- 15 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Frequency and Etiology of Travelers' Diarrhea in Australian Adult Tourists Traveling to Southeast Asia
- ClinicalTrials.gov ID
- NCT06363890
- Acronym / sponsor ID
- AusTD / TD02
- Conditions
- Travelers Diarrhea
- Keywords
- travelers diarrhea, australian, epidemiology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,400 participants (actual)
- Lead sponsor
- Lumen Bioscience, Inc.Industry (pharma, biotech, devices)
- Study start
- 20 Jun 2024 (actual)
- Primary completion
- 1 Mar 2026 (actual)
- Study completion
- 1 Jul 2026 (actual)
- First posted
- 12 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult Australian travelers | – | Diagnostic Test: TAQMan Array Card1200 Healthy Australian adult tourists traveling to Southeast Asia. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 1200 Australian adult tourists traveling to Southeast Asia
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (1 listed)
- Unable or unwilling to provide adequate informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TAQMan Array CardReal time PCR test to detect diarrheal pathogens. | Diagnostic test | Adult Australian travelers |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Travelers Diarrhea, run by Lumen Bioscience, Inc. at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Characterize the frequency and etiology of travelers' diarrhea in this participant population of Australian adult tourists traveling to Southeast Asia. (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2026.