Trial to Evaluate Dietary Supplements to Maintain Gut Health During Travel
Completed · Not applicable · Has a placebo group
Conditions studied: Diarrhea
In brief
Passive immunoprophylaxis is a class of dietary supplements that is lawfully marketed in the US for maintenance of gut health (GH). This randomized, double-blind, clinical trial will evaluate passive immunoprophylaxis (Travelan®) product compared with placebo, to assess the ability to maintain normal gut function during travel. The results of this clinical trial will be used to evaluate the use of a dietary supplement to maintain GH during deployment and travel and is not intended to support a marketing application of any dietary supplement as a drug or biological product for human use.
Key facts
- Study ID
- NCT04605783
- Run by
- Henry M. Jackson Foundation for the Advancement of Military Medicine
- People needed
- 851
- Starts
- 2022-05-27
- Expected to finish
- 2025-06-20
- Last updated by the study team
- 2025-07-17
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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 it is running
- Tripler Army Medical Center — Honolulu, Hawaii, United States
- Naval Medical Center Camp Lejeune — Marine Corps Base Camp Lejeune, North Carolina, United States
- Naval Medical Center Portsmouth — Portsmouth, Virginia, United States
- Madigan Army Medical Center — Tacoma, Washington, United States
- United Kingdom Ministry of Defence — Birmingham, United Kingdom
- The Liverpool School of Tropical Medicine- Well Travelled Clinic — Liverpool, United Kingdom
Full record on ClinicalTrials.gov
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