Trial to Evaluate Dietary Supplements to Maintain Gut Health During Travel

Description

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.

Conditions

Diarrhea

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Study Overview

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Study Details

Study overview

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.

A Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate A Dietary Supplement to Maintain Gut Health During Deployment and Travel

Trial to Evaluate Dietary Supplements to Maintain Gut Health During Travel

Condition
Diarrhea
Intervention / Treatment

-

Contacts and Locations

San Diego

Naval Medical Center San Diego, San Diego, California, United States, 92134

Honolulu

Tripler Army Medical Center, Honolulu, Hawaii, United States, 96859

Camp Lejeune

Naval Medical Center Camp Lejeune, Camp Lejeune, North Carolina, United States, 28547

Portsmouth

Naval Medical Center Portsmouth, Portsmouth, Virginia, United States, 23708

Tacoma

Madigan Army Medical Center, Tacoma, Washington, United States, 98431

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to 70 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Henry M. Jackson Foundation for the Advancement of Military Medicine,

David R Tribble, MD, DrPH, PRINCIPAL_INVESTIGATOR, Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences

Study Record Dates

2025-01-31