Etiology of Travelers' Diarrhea in Australian Tourists Traveling to Southeast Asia
ConditionTravelers Diarrhea
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-100
SponsorLumen Bioscience, Inc.
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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).
Disqualifiers
Unable or unwilling to provide adequate informed consent.
Trial population
1200 Australian adult tourists traveling to Southeast Asia
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
TAQMan Array Card
Diagnostic testReal time PCR test to detect diarrheal pathogens.
Treatment groups
1,200 Participants
are divided into 1 treatment groupGroup A: Adult Australian travelers1 intervention
Trial outcomes
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.
Time frame
18 monthsSponsors and contacts
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Source ClinicalTrials.gov