A Pilot Study Assessing Intestinal Microbiota Diversification and Changes After Travel to South(East) Asia From the US

Completed

Conditions studied: Dysbiosis

In brief

This prospective, observational pilot study is designed to assess feasibility, refine the target population, and quickly test qualitative and quantitative changes in the microbiome after short-term travel to South or Southeast Asia, regions where rates of travelers' diarrhea and intestinal colonization with antimicrobial resistant bacteria are highest. To measure the diversity change of the intestinal microbiota, participants will complete a questionnaire and provide a stool specimen at three different time points: prior to traveling, two weeks after returning from traveling, and 14 weeks after returning from traveling.

Key facts

Study ID

NCT03043300

Run by

Emory University

People needed

10

Starts

2017-11-07

Expected to finish

2018-12-01

Last updated by the study team

2019-01-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Ability to understand and the willingness to sign a written informed consent document.
• Ability and willingness to comply with study protocol requirements.
• Completed screening criteria.
• Departure date for international travel is planned for 4 weeks from the date of informed consent.
• Duration of international travel is planned for a minimum of seven days and maximum of 21 days.
• International travel is planned to at least one of the following countries of South(east) Asia:
• South Asia, defined as: Afghanistan, Bangladesh, Bhutan, India, Maldives, Nepal, Pakistan, Sri Lanka
• Southeast Asia, defined as: Cambodia, Laos, West Malaysia (excluding Malaysian Borneo), Myanmar (Burma), Thailand, Vietnam

You may not qualify if…

• Women of childbearing potential who self-report to be either:
• Currently pregnant
• Planning a pregnancy during study participation
• Current diarrhea (defined as ≥ 3 unformed loose stools in 24 hours)
• Prior episode of diarrhea (defined as ≥ 3 unformed loose stools in 24 hours) in the 12 weeks prior to date of informed consent

Where it is running

• Emory Univeristy Hospital Midtown, TravelWell Center — Atlanta, Georgia, United States
• Emory University — Atlanta, Georgia, United States

Full record on ClinicalTrials.gov

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