Trial to Evaluate Dietary Supplements to Maintain Gut Health During Travel

NCT04605783 | Completed

• 1 other identifier: IDCRP-123
• Study Type: interventional
• Target: 851
• Locations: 2 countries
• Sites: 6

Brief Summary

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

Keywords

Diarrhea, Prevention, Deployment, Supplements

Outcome Measures

Primary Outcomes (1)

• Incidence of gut health deficiencies

  Combined endpoint of incidence of GH deficiencies (defined as 3 or more unformed stools in a 24-hour period) OR 2 or more unformed stools and one or more associated symptoms (nausea, vomiting, abdominal pain, fever, bloody stool) in a 24-hour period OR antibiotic treatment for diarrhea per subject report, during the period of prophylaxis.

  up to 20 days

Study Arms (2)

Travelan®

EXPERIMENTAL

Product will be started 2 days prior to arrival in overseas destination and maintained for a maximum duration of 20 days (minimum of 10 days) during travel or deployment.

Dietary Supplement: Travelan®

Placebo

PLACEBO COMPARATOR

Placebo will be started 2 days prior to arrival in overseas destination and maintained for a maximum duration of 20 days (minimum of 10 days) during travel or deployment.

Other: Placebo

Interventions

Travelan® DIETARY_SUPPLEMENT

Travelan® (600mg) taken as 1 sachet twice daily with meals. Product will be started 2 days prior to arrival and maintained for a maximum duration of 20 days (minimum of 10 days) during travel or deployment.

Travelan®

Placebo OTHER

Maltodextrin - To be started 2 days prior to arrival and maintained for a maximum duration of 20 days (minimum of 10 days) during travel or deployment.

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Henry M. Jackson Foundation for the Advancement of Military Medicine: lead
• Uniformed Services University of the Health Sciences: collaborator

Study Sites (6)

Tripler Army Medical Center

Honolulu, Hawaii, 96859, United States

Location

Naval Medical Center Camp Lejeune

Marine Corps Base Camp Lejeune, North Carolina, 28547, United States

Location

Naval Medical Center Portsmouth

Portsmouth, Virginia, 23708, United States

Location

Madigan Army Medical Center

Tacoma, Washington, 98431, United States

Location

United Kingdom Ministry of Defence

Birmingham, United Kingdom

Location

The Liverpool School of Tropical Medicine- Well Travelled Clinic

Liverpool, United Kingdom

Location

MeSH Terms

Conditions

Diarrhea

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• David R Tribble, MD, DrPH

  Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Randomized, placebo-controlled, double-blind clinical trial
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2020
• First Posted: October 28, 2020
• Study Start: May 27, 2022
• Primary Completion: June 20, 2025
• Study Completion: June 20, 2025
• Last Updated: July 17, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (4); GB (2)