Trial to Evaluate Dietary Supplements to Maintain Gut Health During Travel

Launched by HENRY M. JACKSON FOUNDATION FOR THE ADVANCEMENT OF MILITARY MEDICINE · Oct 23, 2020

Keywords

ClinConnect Summary

This clinical trial is studying a dietary supplement called Travelan® to see if it can help maintain gut health and prevent diarrhea while traveling. Researchers want to find out if this supplement can keep your digestive system functioning normally when you’re away from home, especially in places that may pose a higher risk for gut issues. Participants will be compared to a group taking a placebo, which is a harmless substance that looks like the supplement but has no active ingredients.

To be eligible for this trial, you need to be between 18 and 70 years old, able to read and speak English, and planning to travel for at least 10 days to a location that might disrupt gut health. You will need to provide a stool sample before starting the supplement and be willing to follow up after your trip. However, if you have certain gastrointestinal conditions, have taken antibiotics recently, or plan to use other gut health medications during the study, you may not qualify. Participants can expect guidance throughout the trial and will help contribute to important research on maintaining gut health during travel.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 18-70 years old, able to read and speak English fluently and provide informed consent
• • Travel or deployment with minimum of 10 consecutive days at intermediate to high risk for GH disruption destination (not counting quarantine period)
• • Ability to complete a follow-up visit following return from travel
• • Ability to provide a stool sample prior to start of prophylaxis
• • Willingness to comply with study procedures
• Exclusion Criteria:
• • Subject-reported history of any known functional bowel disorder (including Irritable Bowel Syndrome) or chronic gastrointestinal disease (e.g. Inflammatory Bowel Disease) which in the opinion of the investigator would preclude assessment of study outcomes
• • Antibiotic use within 7 days prior to start of prophylaxis (except for malaria prophylaxis including doxycycline, chloroquine, atovaquone/proguanil, mefloquine, primaquine, and tafenoquine)
• • Experiencing diarrheal illness (defined as 3 or more loose/liquid stools in a 24 hour period) within 3 days prior to start of prophylaxis
• • Planned use of any investigational or non-registered drug, antibiotic or other probiotics or prebiotics (outside of the study product) during the study period. This does not include consumption of yogurt products
• • Intended use of a GH disruption prophylactic (e.g. Pepto-Bismol, rifaximin) during the study period
• • Any planned medication usage during the study period that is deemed by the PI to interfere with GI function including but not limited to anti-diarrheals and prokinetics
• • Any confirmed or suspected cancer, or use of immunosuppressant medication (topical steroids are permitted) in the last 6 months which in the opinion of the investigator would impair interpretation of the study data