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

Diarrhea Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00737412
• Other study ID #: CL1285-TD-M02
• Status: Completed
• Phase: Phase 3
• First received: August 15, 2008
• Last updated: January 19, 2010
• Start date: April 2008
• Est. completion date: January 2010

Study information

• Verified date: January 2010
• Source: Bio-K Plus International Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 277
• Est. completion date: January 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diarrhea
• Dysentery

Intervention

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.
• Placebo
Matching capsules devoid of microorganisms

Locations

Country	Name	City	State
Canada	Clinique Santé Voyage des Prairies	Joliette	Quebec
Canada	Clinique Santé Voyage de Laval	Laval	Quebec
Canada	Clinique Santé Voyage Saint-Luc	Montreal	Quebec
Canada	Sant Voyage Medisys	Montreal	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Bio-K Plus International Inc.	ethica Clinical Research Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	To compare the safety profile of BIO-K+CL1285 RX® to that of placebo		March 2008 to April 2009
Secondary	To compare the physician and traveler satisfaction following daily prophylaxis with either BIO-K+CL1285 RX® or placebo		March 08 to April 09
Secondary	To evaluate and compare the health economic impact of daily prophylaxis with BIO-K+CL1285 RX®.		March 08 to April 09