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

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.

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

Study Overview

• Status: Completed
• Conditions: Diarrhea
• Intervention / Treatment: Other: Probiotic: Bio-K+ CL1285; Other: Placebo

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 277
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Joliette, Quebec, Canada, J6E 1G2
      • Clinique Santé Voyage des Prairies
    • Laval, Quebec, Canada, H7G2E6
      • Clinique Santé Voyage de Laval
    • Montreal, Quebec, Canada, H2X 2H9
      • Clinique Santé Voyage Saint-Luc
    • Montreal, Quebec, Canada, H3A 3C6
      • Sant Voyage Medisys

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 2; Placebo	Other: Placebo; Matching capsules devoid of microorganisms
Active Comparator: 1; The probiotic Bio-K+ CL1285 RX®	Other: 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.; Other Names: Bio-K+ CL1285 RX®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Bio-K Plus International Inc.
• Collaborators: ethica Clinical Research Inc.
• Investigators: Principal Investigator: Dominique Tessier, MD, Sante Voyage Medisys; Principal Investigator: Benoit Brizard, MD, Clinique Santé Voyage de Laval; Principal Investigator: Benoit Cote, MD, Clinique Santé Voyage des Prairies; Principal Investigator: Jean Vincelette, MD, Sante Voyage Saint-Luc

Study record dates

Study Major Dates

• Study Start: April 1, 2008
• Primary Completion (Actual): December 1, 2009
• Study Completion (Actual): January 1, 2010

Study Registration Dates

• First Submitted: August 15, 2008
• First Submitted That Met QC Criteria: August 18, 2008
• First Posted (Estimate): August 19, 2008

Study Record Updates

• Last Update Posted (Estimate): January 21, 2010
• Last Update Submitted That Met QC Criteria: January 19, 2010
• Last Verified: January 1, 2010

More Information

Terms related to this study

• Keywords: Probiotics; Bio-K+CL1285; Traveler's Diarrhea; Lactobacillus Acidophilus; Lactobacillus Casei
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Diarrhea
• Other Study ID Numbers: CL1285-TD-M02