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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

277 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2010-01-31

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.

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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.

Conditions

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Diarrhea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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1

The probiotic Bio-K+ CL1285 RX®

Group Type ACTIVE_COMPARATOR

Probiotic: Bio-K+ CL1285

Intervention Type OTHER

The probiotic Bio-K+ CL1285 RX®, a mixture of Lactobacillus acidophilus and Lactobacillus casei, contains over 50 billion living bacteria per administered dose.

2

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Matching capsules devoid of microorganisms

Interventions

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Probiotic: Bio-K+ CL1285

The probiotic Bio-K+ CL1285 RX®, a mixture of Lactobacillus acidophilus and Lactobacillus casei, contains over 50 billion living bacteria per administered dose.

Intervention Type OTHER

Placebo

Matching capsules devoid of microorganisms

Intervention Type OTHER

Other Intervention Names

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Bio-K+ CL1285 RX®

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes