Clinical trial NCT00737412: Efficacy of BIO-K+ CL1285® Prophylaxis in the Prevention of Traveler's Diarrhea in Adults
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diarrhea
Keywords: Bio-K+CL1285
Probiotics
Traveler's Diarrhea
Lactobacillus Acidophilus
Lactobacillus Casei
Lead sponsor: Bio-K Plus International Inc.
Sponsor class: INDUSTRY
Collaborators: name: ethica Clinical Research Inc.
First posted: 2008-08-19
Enrollment: 277
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

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 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

Primary outcomes:
measure: 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.
timeFrame: March 2008 to April 2009
Secondary outcomes:
measure: 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.
timeFrame: March 2008 to April 2009
measure: To compare the safety profile of BIO-K+CL1285 RX® to that of placebo
timeFrame: March 2008 to April 2009
measure: To compare the physician and traveler satisfaction following daily prophylaxis with either BIO-K+CL1285 RX® or placebo
timeFrame: March 08 to April 09
measure: To evaluate and compare the health economic impact of daily prophylaxis with BIO-K+CL1285 RX®.
timeFrame: March 08 to April 09
Other outcomes:
Locations:
city: Joliette
country: Canada
facility: Clinique Santé Voyage des Prairies
state: Quebec
city: Laval
country: Canada
facility: Clinique Santé Voyage de Laval
state: Quebec
city: Montreal
country: Canada
facility: Clinique Santé Voyage Saint-Luc
state: Quebec
city: Montreal
country: Canada
facility: Sant Voyage Medisys
state: Quebec
Study officials:
affiliation: Sante Voyage Medisys
name: Dominique Tessier, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinique Santé Voyage de Laval
name: Benoit Brizard, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinique Sante Voyage des Prairies
name: Benoit Cote, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sante Voyage Saint-Luc
name: Jean Vincelette, MD
role: PRINCIPAL_INVESTIGATOR
References: