Evaluating a dietary supplement for gut health during travel
A Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate A Dietary Supplement to Maintain Gut Health During Deployment and Travel
This study tests if a dietary supplement called Travelan® can help military personnel and travelers keep their gut healthy while traveling to places that might upset their stomachs.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 866 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Henry M. Jackson Foundation for the Advancement of Military Medicine Academic / other |
| Locations | 7 sites (San Diego, California and 6 other locations) |
| Trial ID | NCT04605783 on ClinicalTrials.gov |
What this trial studies
This clinical trial assesses the effectiveness of a dietary supplement called Travelan® in maintaining gut health during travel, compared to a placebo. It is a randomized, double-blind study involving deployed military personnel and travelers from the US and UK. Participants will take the supplement or placebo twice daily for a minimum of 10 days while traveling to destinations at risk for gut health disruption. Stool samples will be collected to evaluate gut function throughout the study.
Who should consider this trial
Good fit: Ideal candidates are healthy adults aged 18-70 who are traveling or deployed for at least 10 consecutive days to areas at risk for gut health issues.
Not a fit: Patients with known functional bowel disorders or chronic gastrointestinal diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help prevent diarrhea and maintain gut health for travelers and military personnel.
How similar studies have performed: Other studies have shown promise in using dietary supplements for gut health, but this specific approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
San Diego, California and 6 other locations
- Naval Medical Center San Diego — San Diego, California, United States (Withdrawn)
- Tripler Army Medical Center — Honolulu, Hawaii, United States (Recruiting)
- Naval Medical Center Camp Lejeune — Camp Lejeune, North Carolina, United States (Completed)
- Naval Medical Center Portsmouth — Portsmouth, Virginia, United States (Active_not_recruiting)
- Madigan Army Medical Center — Tacoma, Washington, United States (Recruiting)
- United Kingdom Ministry of Defence — Birmingham, United Kingdom (Active_not_recruiting)
- The Liverpool School of Tropical Medicine- Well Travelled Clinic — Liverpool, United Kingdom (Recruiting)
Study contacts
- Principal investigator: David R Tribble, MD, DrPH — Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences
- Study coordinator: David R Tribble, MD, DrPH
- Email: david.tribble@usuhs.edu
- Phone: (240) 694-2948
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.