P3: Trial to Evaluate Dietary Supplements to Maintain Gut Health During Travel
Study Details
Study Description
Brief Summary
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 two commercially available dietary supplement products (probiotic (Florastor®) and passive immunoprophylaxis (Travelan®), each 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 dietary supplements 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
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 two commercially available dietary supplement products (probiotic (Florastor®) and passive immunoprophylaxis (Travelan®), each 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 dietary supplements 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 two dietary supplement products: Florastor® and Travelan®, each compared with placebo for maintenance of GH during and immediately after travel. Enrollment of 1302 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, the UK military, and at a civilian travel clinic in New York City. Subjects will be randomized to receive a masked regimen of Florastor®, Travelan®, or placebo taken as 1 sachet twice daily with meals. Chemoprophylaxis will be started 3 days prior to arrival and maintained for a duration 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 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, focusing on a 10 day window of prophylaxis during travel. 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 four 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Florastor® Product will be started 3 days prior to arrival in overseas destination and maintained for a duration of 10 days during travel or deployment. |
Dietary Supplement: Florastor®
Florastor® (500mg) taken as 1 sachet twice daily with meals. Product will be started 3 days prior to arrival and maintained for a duration of 10 days during travel or deployment.
|
| Experimental: Travelan® Product will be started 3 days prior to arrival in overseas destination and maintained for a duration of 10 days during travel or deployment. |
Dietary Supplement: Travelan®
Travelan® (600mg) taken as 1 sachet twice daily with meals. Product will be started 3 days prior to arrival and maintained for a duration of 10 days during travel or deployment.
|
| Placebo Comparator: Placebo Placebo will be started 3 days prior to arrival in overseas destination and maintained for a duration of 10 days during travel or deployment. |
Other: Placebo
Maltodextrin - To be started 3 days prior to arrival and maintained for a duration of 10 days during travel or deployment.
|
Outcome Measures
Primary Outcome Measures
- Incidence of gut health deficiencies [10 day window of prophylaxis during travel.]
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, focusing on a 10 day window of prophylaxis during travel.
Secondary Outcome Measures
- Compliance and tolerability [During and up to 30 days after travel/deployment]
An evaluation of compliance with each dietary supplement and tolerability (e.g. taste, bloating, flatulence, etc.)
- Differences in gut health associated enteropathogen distribution [During travel through time of return to US]
Distribution of enteropathogens among the four treatment groups will be determined by testing stool smears collected by subjects during a GH deficit using a polymerase chain reaction (PCR) assay.
Eligibility Criteria
Criteria
Inclusion Criteria:
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18-70 years old, able to read and speak English fluently and provide informed consent
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Travel or deployment with minimum of 10 consecutive days at intermediate to high risk for GH disruption destination
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Ability to complete a follow-up visit within 30 days of the end of taking study product
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Departure date ≥ 7 days from the date of enrollment
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Willingness to comply with study procedures
Exclusion Criteria:
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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
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Antibiotic use within 7 days prior to enrollment (except for malaria prophylaxis including doxycycline, chloroquine, atovaquone/proguanil, mefloquine, primaquine, and tafenoquine)
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Experiencing diarrheal illness (defined as 3 or more loose/liquid stools in a 24 hour period) within 3 days prior to enrollment
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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
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Intended use of a GH disruption prophylactic (e.g. Pepto-Bismol, rifaximin) during the study period
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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
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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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Naval Medical Center San Diego | San Diego | California | United States | 92134 |
| 2 | Tripler Army Medical Center | Honolulu | Hawaii | United States | 96859 |
| 3 | New York Center for Travel and Tropical Medicine | New York | New York | United States | 10022 |
| 4 | Naval Medical Center Camp Lejeune | Camp Lejeune | North Carolina | United States | 28547 |
| 5 | Naval Medical Center Portsmouth | Portsmouth | Virginia | United States | 23708 |
| 6 | Madigan Army Medical Center | Tacoma | Washington | United States | 98431 |
| 7 | United Kingdom Ministry of Defence | Birmingham | United Kingdom |
Sponsors and Collaborators
- Uniformed Services University of the Health Sciences
- US Defense Health Program
Investigators
- Principal Investigator: David R Tribble, MD, DrPH, Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IDCRP-123