Efficacy of BIO-K+ CL1285® Prophylaxis in the Prevention of Traveler's Diarrhea in Adults

Study Overview
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Brief Summary
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The purpose of this study is to determine the efficacy of Bio-K+ CL1285 in reducing traveler's diarrhea.

Detailed Description
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Determine efficacy of Bio-K+ CL1285 in reducing Traveler's Diarrhea by comparing the incidence of diarrhea in travelers during their stay abroad and upon their return to Canada following either Bio-K+ CL-1285 OR placebo prophylaxis.

Official Title
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A Double-blind, Randomized, Placebo Controlled, Multicenter Study of the Efficacy of BIO-K+ CL1285® Prophylaxis in the Prevention of Traveler's Diarrhea in Adults.

Conditions
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Diarrhea

Intervention / Treatment
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* Other: Probiotic: Bio-K+ CL1285
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female subjects over 18 years of age traveling to Mexico, Central America, South America and Caribbean Islands as direct destinations or on cruises to the same destinations. The trips last a minimum of 7 days and a maximum of 21 days. Women of child bearing capacity who are not pregnant at the moment of screening (pregnancy test done on-site) and agree to use an acceptable form of birth control for the duration of the study (e.g. Condom, oral contraceptives, etc.) are allowed to participate. Exclusion Criteria: active diarrhea; pregnancy; breastfeeding 3 diarrheic episodes within 24 hours in the 15 days preceding the date of the departure; antibiotic treatment during the last 15 days or ongoing treatment at the time of departure; consumption of fermented milk, yogourt or probiotics probiotics in the 15 days preceding the date of the departure; immunosuppressed state or any health condition being susceptible to decompensate during the study (including malignant hemo-pathologies, AIDS, bone marrow transplant or organ transplant). active radiotherapy or chemotherapy as cancer treatment the administration of an ETEC/cholera vaccine or any other diarrhea vaccine in the three months prior to study initiation an active, non-controlled intestinal disease; ileostomy, jejunostomy or colostomy concomitant participation in another clinical trial mental or other conditions, or language barriers rendering the subject unable to understand the nature, scope, and possible consequences of the study or complete the self-administered questionnaires; subject unlikely to comply with protocol, e.g., uncooperative attitude, and unlikelihood of completing the study, allergies to any ingredients in the study product (active product or placebo) current use of illicit drug and alcohol abuse

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>The probiotic Bio-K+ CL1285 RX® | Other: Probiotic: Bio-K+ CL1285<br>* The probiotic Bio-K+ CL1285 RX®, a mixture of Lactobacillus acidophilus and Lactobacillus casei, contains over 50 billion living bacteria per administered dose.<br>* Other names: Bio-K+ CL1285 RX®;|
| Placebo Comparator: 2<br>Placebo | Other: Placebo<br>* Matching capsules devoid of microorganisms<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the efficacy of Bio-K+ CL1285 RX® in reducing traveler's diarrhea by comparing the incidence of diarrhea in travelers during their stay abroad and upon their return to Canada, following either BIO-K+CL1285 RX® or placebo prophylaxis. |  | March 2008 to April 2009 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare the severity of diarrhea in travelers during their stay abroad and upon their return to Canada, following either BIO-K+CL1285 RX® or placebo prophylaxis. |  | March 2008 to April 2009 | 
| To compare the safety profile of BIO-K+CL1285 RX® to that of placebo |  | March 2008 to April 2009 | 
| To compare the physician and traveler satisfaction following daily prophylaxis with either BIO-K+CL1285 RX® or placebo |  | March 08 to April 09 | 
| To evaluate and compare the health economic impact of daily prophylaxis with BIO-K+CL1285 RX®. |  | March 08 to April 09 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bio-K+CL1285, Probiotics, Traveler's Diarrhea, Lactobacillus Acidophilus, Lactobacillus Casei