Trial to Evaluate Dietary Supplements to Maintain Gut Health During Travel

Summary

Participation Requirements

Description

Prebiotics, 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 three commercially available dietary supplement products: (Bimuno, federally re...

Prebiotics, 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 three commercially available dietary supplement products: (Bimuno, federally registered with the United States [US] Patent and Trademark Office [®]), probiotic (Florastor®), and passive immunoprophylaxis (Travelan®) product, 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 three dietary supplement products: Bimuno®, Florastor®, and Travelan®, each compared with placebo for maintenance of GH during and immediately after travel. Enrollment of 1320 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 over a 2-year period. Subjects will be randomized to receive a masked regimen of Bimuno®, 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. A follow-up electronic survey completed at 3- and 6-months post-travel/deployment will assess and record whether there are known or unknown diseases associated with GH deficits such as incident functional gastrointestinal disorders (FGD) and reactive arthritis (ReA). 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 an d 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. Risk of incident FGD and ReA in subjects in the dietary supplement arms vs. placebo will be assessed using electronic surveys administered 3- and 6- months following return from travel/deployment. 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.

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