COMPLETED

Trial to Evaluate Dietary Supplements to Maintain Gut Health During Travel

Conditions

Diarrhea Diarrhea, Prevention, Deployment, Supplements

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2022-05-27

Study Completion:2025-06-20

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT04605783

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.

Ages Eligible for Study:18 Years to 70 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Principal Investigator

David R Tribble, MD, DrPH

PRINCIPAL_INVESTIGATOR

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

Study Locations (Sites)

Tripler Army Medical Center

Honolulu, Hawaii, 96859

United States

Naval Medical Center Camp Lejeune

Camp Lejeune, North Carolina, 28547

United States

Naval Medical Center Portsmouth

Portsmouth, Virginia, 23708

United States

Madigan Army Medical Center

Tacoma, Washington, 98431

United States

Collaborators and Investigators

Sponsor: 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-05-27

Study Completion Date2025-06-20

Study Record Updates

Study Start Date2022-05-27

Study Completion Date2025-06-20

Terms related to this study

Keywords Provided by Researchers

Diarrhea, Prevention, Deployment, Supplements

Additional Relevant MeSH Terms

Diarrhea