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

NCT00737412 | Completed Phase 3 DMC

• 1 other identifier: CL1285-TD-M02
• Study Type: interventional
• Target: 277
• Locations: 1 country
• Sites: 4

Brief Summary

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

Conditions

Diarrhea

Keywords

Bio-K+CL1285; Probiotics; Traveler's Diarrhea; Lactobacillus Acidophilus; Lactobacillus Casei

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

Study Arms (2)

1

ACTIVE COMPARATOR

The probiotic Bio-K+ CL1285 RX®

Other: Probiotic: Bio-K+ CL1285

2

PLACEBO COMPARATOR

Placebo

Other: Placebo

Interventions

Probiotic: Bio-K+ CL1285 OTHER

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

Also known as: Bio-K+ CL1285 RX®

1

Placebo OTHER

Matching capsules devoid of microorganisms

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• active diarrhea;
• pregnancy; breastfeeding
• 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

Sponsors & Collaborators

• Bio-K Plus International Inc.: lead
• ethica Clinical Research Inc.: collaborator

Study Sites (4)

Clinique Santé Voyage des Prairies

Joliette, Quebec, J6E 1G2, Canada

Location

Clinique Santé Voyage de Laval

Laval, Quebec, H7G2E6, Canada

Location

Clinique Santé Voyage Saint-Luc

Montreal, Quebec, H2X 2H9, Canada

Location

Sant Voyage Medisys

Montreal, Quebec, H3A 3C6, Canada

Location

MeSH Terms

Conditions

Diarrhea

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 15, 2008
• First Posted: August 19, 2008
• Study Start: April 1, 2008
• Primary Completion: December 1, 2009
• Study Completion: January 1, 2010
• Last Updated: January 21, 2010

Record last verified: 2010-01

Locations

CA (4)