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

This study has been completed.
Sponsor:
Collaborator:
ethica Clinical Research Inc.
Information provided by:
Bio-K Plus International Inc.
ClinicalTrials.gov Identifier:
NCT00737412
First received: August 15, 2008
Last updated: January 19, 2010
Last verified: January 2010
  Purpose

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


Condition Intervention Phase
Diarrhea
Other: Probiotic: Bio-K+ CL1285
Other: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by Bio-K Plus International Inc.:

Primary Outcome Measures:
  • 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. [ Time Frame: March 2008 to April 2009 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. [ Time Frame: March 2008 to April 2009 ] [ Designated as safety issue: No ]
  • To compare the safety profile of BIO-K+CL1285 RX® to that of placebo [ Time Frame: March 2008 to April 2009 ] [ Designated as safety issue: Yes ]
  • To compare the physician and traveler satisfaction following daily prophylaxis with either BIO-K+CL1285 RX® or placebo [ Time Frame: March 08 to April 09 ] [ Designated as safety issue: No ]
  • To evaluate and compare the health economic impact of daily prophylaxis with BIO-K+CL1285 RX®. [ Time Frame: March 08 to April 09 ] [ Designated as safety issue: No ]

Enrollment: 277
Study Start Date: April 2008
Study Completion Date: January 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Bio-K+ CL1285 RX®
Placebo Comparator: 2
Placebo
Other: Placebo
Matching capsules devoid of microorganisms
Other Name: 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00737412

Locations
Canada, Quebec
Clinique Santé Voyage des Prairies
Joliette, Quebec, Canada, J6E 1G2
Clinique Santé Voyage de Laval
Laval, Quebec, Canada, H7G2E6
Sant Voyage Medisys
Montreal, Quebec, Canada, H3A 3C6
Clinique Santé Voyage Saint-Luc
Montreal, Quebec, Canada, H2X 2H9
Sponsors and Collaborators
Bio-K Plus International Inc.
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 Sante Voyage des Prairies
Principal Investigator: Jean Vincelette, MD Sante Voyage Saint-Luc
  More Information

No publications provided

Responsible Party: Marcia T. Ruiz, Bio-K+ International Inc.
ClinicalTrials.gov Identifier: NCT00737412     History of Changes
Other Study ID Numbers: CL1285-TD-M02
Study First Received: August 15, 2008
Last Updated: January 19, 2010
Health Authority: Canada: Health Canada

Keywords provided by Bio-K Plus International Inc.:
Bio-K+CL1285
Probiotics
Traveler's Diarrhea
Lactobacillus Acidophilus
Lactobacillus Casei

Additional relevant MeSH terms:
Diarrhea
Dysentery
Signs and Symptoms, Digestive
Signs and Symptoms
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on April 22, 2014