A Pilot Study Assessing Intestinal Microbiota Diversification and Changes After Travel to South(Eā¦ (NCT03043300) | Clinical Trial Compass
CompletedNot Applicable
A Pilot Study Assessing Intestinal Microbiota Diversification and Changes After Travel to South(East) Asia From the US
United States10 participantsStarted 2017-11-07
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
ā. Ability to understand and the willingness to sign a written informed consent document.
ā. Ability and willingness to comply with study protocol requirements.
ā. Completed screening criteria.
ā. Departure date for international travel is planned for 4 weeks from the date of informed consent.
ā. Duration of international travel is planned for a minimum of seven days and maximum of 21 days.
ā. International travel is planned to at least one of the following countries of South(east) Asia:
ā. South Asia, defined as: Afghanistan, Bangladesh, Bhutan, India, Maldives, Nepal, Pakistan, Sri Lanka
ā. Southeast Asia, defined as: Cambodia, Laos, West Malaysia (excluding Malaysian Borneo), Myanmar (Burma), Thailand, Vietnam
Exclusion criteria
ā. Women of childbearing potential who self-report to be either:
What they're measuring
1
Change in Predominant Intestinal Microbiota Genus or Strain
Timeframe: Pre-travel to 14 Weeks Post-Travel
2
Change in Alpha and Beta Diversity of Intestinal Microbiota
Timeframe: Pre-travel to 14 Weeks Post-Travel
3
Change in Firmicutes:Bacteroides Ratio of Microbiota