MedTrace Logo

Trial to Evaluate Dietary Supplements to Maintain Gut Health During Travel

NCT04605783 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 851

Last updated 2025-07-17

No results posted yet for this study

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

Interventions

DIETARY_SUPPLEMENT

Travelan®

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.

OTHER

Placebo

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.

Sponsors & Collaborators

  • Uniformed Services University of the Health Sciences

    collaborator FED

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

    lead OTHER

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-05-27
Primary Completion
2025-06-20
Completion
2025-06-20

Countries

  • United States
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04605783 on ClinicalTrials.gov