Efficacy and Safety of BIO-K + CL1285 in Prevention of Antibiotic-associated Diarrhea in Hospitalized Adult Patients
Condition: Diarrhea; Clostridium Infections
MeSH terms: Infections; Clostridium Infections; Diarrhea
Intervention: Lactobacillus acidophilus CL1285 and Lactobacillus casei; placebo
Intervention description: One bottle daily 2 hours before or after antibiotic administration and for 5 days following the termination of antibiotic regimen.; One bottle daily 2 hours before or after antibiotic administration and for 5 days following the termination of antibiotic regimen.
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 472.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Bio-K+CL1285; Probiotics; Antibiotics-associated diarrhea; Clostridium difficile-associated diarrhea; Lactobacillus acidophilus; Clostridium Difficile

Summary:

      The purpose of this study is to evaluate the efficacy and safety of Bio-K + CL1285 versus
      placebo in the prevention of antibiotic-associated diarrhea in hospitalized adult patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  presenting to the Emergency Room and considered for admission to hospital for a
             minimum of 12 hours and requiring antibiotic administration for the treatment of a
             suspected or proven bacterial infection OR a hospitalized patient developing a
             suspected or proven nosocomial infection OR an external patient that come to the
             hospital for repeated visits to receive his intravenous antibiotic therapy for the
             treatment of a suspected or proven bacterial infection. The external patients on oral
             antibiotics that come to the hospital for repeated visits to receive any other
             treatments requiring a hospital stay of more than one hour will also be included.

          -  Hospital employee on antibiotics can also be included in the study

          -  having received less than 24 hours of antibiotic therapy;

          -  requiring a minimum of 3 days and a maximum of 14 days antibiotic administration

        Informed consent must be obtained in writing for all subjects at enrollment into the study

        Exclusion Criteria:

        Subjects presenting with any of the following will not be included in the study:

          -  active diarrhea;

          -  a history of daily consumption of fermented milk and/or yogurt;

          -  intolerance to lactose;

          -  pregnant/breastfeeding women;

          -  an active, non controlled intestinal disease such as Crohn's Disease or ulcerative
             colitis;

          -  ileostomy, jejunostomy or colostomy;

          -  immunosuppressed state;

          -  a previous documented C. difficile infection in the three months prior to study
             initiation;

          -  active radiotherapy or chemotherapy;

          -  recent (< 6 months) or planned bone marrow graft or organ transplant;

          -  antibiotic therapy in the fourteen days prior to study initiation;

          -  the planned administration of metronidazole (alone or in combination) or vancomycin
             monotherapy for the treatment of an infection;

          -  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, inability to
             return for follow-up visits, and unlikelihood of completing the study.

        Post-enrollment exclusion criteria include fermented milk and/or yogurt consumption during
        the study period and two consecutive missed dose of study product.