Efficacy and Safety Study in the Prevention of Antibiotic-Associated Diarrhea (AAD) and Clostridium Difficile-Associated Diarrhea (CDAD) in Hospitalized Adult Patients Exposed to Nosocomial Infection
Condition: Antibiotic-Associated Diarrhea; Clostridium Difficile-Associated Diarrhea
MeSH terms: Clostridium Infections; Cross Infection; Diarrhea
Intervention: BIO-K+ CL-1285®; Placebo
Intervention description: A mixture of Lactobacillus acidophilus and Lactobacillus casei, contains over 50 billion living bacteria per administered dose.; Placebo is devoid of microorganisms.
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 255.0
Sex: All
Minimum age: 50 Years
Maximum age: 70 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Probiotic; Antibiotic-Associated Diarrhea (AAD) Prevention; Clostridium Difficile-Associated Diarrhea (CDAD)Prevention

Summary:

      The purpose of this study is to evaluate the efficacy and safety of Bio-K+ CL-1285 in the
      prevention of Antibiotic-Associated Diarrhea (AAD) and Clostridum difficile-Associated
      Diarrhea (CDAD) in hospitalized patients exposed to nosocomial infection.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Antibiotic therapy for a minimum of 3 days and a maximum of 14 days

          -  Expected to remain hospitalized for a minimum of 5 days

          -  Patients who have received less than 36 hours of antibiotic therapy

          -  Negative pregnancy test at screening

          -  Obtained his/her informed consent after verbal and written information

          -  Patients having a telephone available (mobile, work, home)

          -  Patients having a fridge at home

        Exclusion Criteria:

          -  Pregnant or breastfeeding women

          -  Patients presenting with active diarrhea (3 or more liquid stools per 24 hour period).

          -  Patients with a history of daily consumption of probiotics, fermented milk and/or
             yogurt;

          -  Patients known to have shown a previous reaction, including anaphylaxis, to any
             substance in composition of the study product (i.e. Non-medicinal ingredients:
             Cellulose, hypromellose, magnesium stearate (vegetal source), ascorbic acid, Colloidal
             silicon dioxide)

          -  Patients presenting with an active, non-controlled intestinal disease such as Crohn's
             Disease or ulcerative colitis;

          -  A previous documented C. Difficile infection < 3 months prior to study initiation ;

          -  Ostomized patients, parenteral nutrition users

          -  Patients with an immunosuppressive therapy or any health condition causing
             immunosuppression (including haematological malignancies, acquired immune deficiency
             syndrome (AIDS))

          -  Ongoing or recent use of antibiotic therapy in the 30 days prior to the study product
             first administration.

          -  Patients with planned administration of antibiotics other than broad spectrum
             Penicillin, Cephalosporin or Clindamycin for the treatment of an infection;

          -  Patients with concomitant participation in another clinical trial;

          -  Patients who are not likely to comply with study requirements