A Pilot Study Assessing Intestinal Microbiota Diversification and Changes After Travel to South(E… (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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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