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Trial to Evaluate Dietary Supplements to Maintain Gut Health During Travel (P2)

Primary Purpose

Diarrhea

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Travelan®
Placebo
Sponsored by
Henry M. Jackson Foundation for the Advancement of Military Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diarrhea focused on measuring Diarrhea, Prevention, Deployment, Supplements

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion 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
  • Ability to complete a follow-up visit within 30 days of the end of taking study product
  • Departure date ≥ 7 days from the date of enrollment
  • Willingness to comply with study procedures

Exclusion Criteria:

  • 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 enrollment (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 enrollment
  • 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

Sites / Locations

  • Naval Medical Center San Diego
  • Tripler Army Medical CenterRecruiting
  • Naval Medical Center Camp LejeuneRecruiting
  • Naval Medical Center PortsmouthRecruiting
  • Madigan Army Medical CenterRecruiting
  • United Kingdom Ministry of DefenceRecruiting
  • The Liverpool School of Tropical Medicine- Well Travelled Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Travelan®

Placebo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
September 16, 2020
Last Updated
August 1, 2023
Sponsor
Henry M. Jackson Foundation for the Advancement of Military Medicine
Collaborators
Uniformed Services University of the Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT04605783
Brief Title
Trial to Evaluate Dietary Supplements to Maintain Gut Health During Travel
Acronym
P2
Official Title
A Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate A Dietary Supplement to Maintain Gut Health During Deployment and Travel
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 27, 2022 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Henry M. Jackson Foundation for the Advancement of Military Medicine
Collaborators
Uniformed Services University of the Health Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Probiotics and passive immunoprophylaxis are classes of dietary supplements that are lawfully marketed in the US for maintenance of gut health (GH). This randomized, double-blind, clinical trial will evaluate one commercially available dietary supplement products (passive immunoprophylaxis (Travelan®), compared with placebo, to assess their ability to maintain normal gut function during travel. The results of this clinical trial will be used to evaluate the use of Travelan® 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. This study is a multi-site, randomized, placebo-controlled, double-blind clinical trial conducted on travelers and deployed US and United Kingdom (UK) military personnel. The study will test Travelan®, compared with placebo for maintenance of GH during and immediately after travel. Enrollment of 868 deployed military personnel or travelers will occur at sites within the Uniformed Services University of the Health Sciences (USU) Infectious Disease Clinical Research Program (IDCRP) network and the UK military. Subjects will be randomized to receive a masked regimen of Travelan® or placebo taken as 1 sachet twice daily with meals. Chemoprophylaxis 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. Stool smears collected during travel will be used for evaluating the microbiome and for gut pathogen identification. Paired (pre and post-supplement administration) sera and stool samples (pre- and post-supplement administration) will be collected for testing of exploratory objectives. Primary Endpoint (Efficacy): The primary efficacy endpoint is the combined endpoint of incidence of GH disruption (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. Primary endpoint data will be obtained from review of the Travel Diary. Secondary Objectives: Secondary endpoints will include an evaluation of compliance with each dietary supplement and tolerability (e.g. taste, bloating, flatulence, etc.); these will be assessed using the Travel Diary. Differences in GH associated enteropathogen distribution among the 2 treatment groups will be determined by testing stool smears collected by subjects during a GH deficit using a polymerase chain reaction (PCR) assay. Exploratory objectives related to changes in the gut microbiome with dietary supplement use and proteomic signatures of the host-pathogen interaction will be addressed contingent on the availability of additional funding.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diarrhea
Keywords
Diarrhea, Prevention, Deployment, Supplements

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Masking Description
Randomized, placebo-controlled, double-blind clinical trial
Allocation
Randomized
Enrollment
868 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Travelan®
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Travelan®
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Incidence of gut health deficiencies
Description
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.
Time Frame
up to 20 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
David R Tribble, MD, DrPH
Phone
(240) 694-2948
Email
david.tribble@usuhs.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Tahaniyat Lalani, MD
Phone
(240)694-2948
Email
tlalani@idcrp.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David R Tribble, MD, DrPH
Organizational Affiliation
Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Naval Medical Center San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92134
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alison Lane, MD, MS
Email
alison.b.lane.mil@health.mil
Facility Name
Tripler Army Medical Center
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96859
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anthony Cancio, MD
Email
anthony.t.cancio.mil@health.mil
Facility Name
Naval Medical Center Camp Lejeune
City
Camp Lejeune
State/Province
North Carolina
ZIP/Postal Code
28547
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michelle Rizzo-Pelley, MD
Email
michelle.rizzopelley@usmc.mil
Facility Name
Naval Medical Center Portsmouth
City
Portsmouth
State/Province
Virginia
ZIP/Postal Code
23708
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christie Joya, MD
Email
christie.a.joya.mil@health.mil
Facility Name
Madigan Army Medical Center
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98431
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sean Turner, MD
Email
sean.p.turner21.mil@health.mil
Facility Name
United Kingdom Ministry of Defence
City
Birmingham
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tom Troth, MD
Email
troth92@doctors.org.uk
Facility Name
The Liverpool School of Tropical Medicine- Well Travelled Clinic
City
Liverpool
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sylviane Defres
Email
sylviane.defres@lstmed.ac.uk

12. IPD Sharing Statement

Plan to Share IPD
No

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Trial to Evaluate Dietary Supplements to Maintain Gut Health During Travel

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