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

Last updated: January 19, 2010
Sponsor: Bio-K Plus International Inc.
Overall Status: Completed

Phase

3

Condition

Lactose Intolerance

Colic

Gastroenteritis

Treatment

N/A

Clinical Study ID

NCT00737412
CL1285-TD-M02
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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

Eligibility Criteria

Inclusion

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 samedestinations.

  • 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 forthe duration of the study (e.g. Condom, oral contraceptives, etc.) are allowed toparticipate.

Exclusion

Exclusion Criteria:

  • active diarrhea;

  • pregnancy; breastfeeding

  • 3 diarrheic episodes within 24 hours in the 15 days preceding the date of thedeparture;

  • antibiotic treatment during the last 15 days or ongoing treatment at the time ofdeparture;

  • consumption of fermented milk, yogourt or probiotics probiotics in the 15 dayspreceding the date of the departure;

  • immunosuppressed state or any health condition being susceptible to decompensateduring the study (including malignant hemo-pathologies, AIDS, bone marrow transplantor organ transplant).

  • active radiotherapy or chemotherapy as cancer treatment

  • the administration of an ETEC/cholera vaccine or any other diarrhea vaccine in thethree 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 tounderstand the nature, scope, and possible consequences of the study or complete theself-administered questionnaires;

  • subject unlikely to comply with protocol, e.g., uncooperative attitude, andunlikelihood 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 Design

Total Participants: 277
Study Start date:
April 01, 2008
Estimated Completion Date:
January 31, 2010

Study 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.

Connect with a study center

  • Clinique Santé Voyage des Prairies

    Joliette, Quebec J6E 1G2
    Canada

    Site Not Available

  • Clinique Santé Voyage de Laval

    Laval, Quebec H7G2E6
    Canada

    Site Not Available

  • Clinique Santé Voyage Saint-Luc

    Montreal, Quebec H2X 2H9
    Canada

    Site Not Available

  • Sant Voyage Medisys

    Montreal, Quebec H3A 3C6
    Canada

    Site Not Available

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