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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

255 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2009-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Antibiotic-Associated Diarrhea Clostridium Difficile-Associated Diarrhea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Placebo

Two capsules of placebo (devoid of microorganisms) per day. Patients took their daily dose 2h after breakfast and antibiotic administration each day. Patients were then followed for an additionnal 21 days after completion of the assigned intervention.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo is devoid of microorganisms.

BIO-K+ CL-1285

Two probiotic capsules (BIO-K+ CL-1285®) per day. Patients took their daily dose 2h after breakfast and antibiotic administration each day. Patients were then followed for an additionnal 21 days after completion of the assigned intervention.

Group Type ACTIVE_COMPARATOR

BIO-K+ CL-1285®

Intervention Type OTHER

A mixture of Lactobacillus acidophilus and Lactobacillus casei, contains over 50 billion living bacteria per administered dose.

BIO-K+ CL-1285® & placebo

One probiotic capsule (BIO-K+ CL-1285®) and one placebo capsule (devoid of microorganisms) per day. Patients took their daily dose 2h after breakfast and antibiotic administration each day. Patients were then followed for an additionnal 21 days after completion of the assigned intervention.

Group Type OTHER

BIO-K+ CL-1285®

Intervention Type OTHER

A mixture of Lactobacillus acidophilus and Lactobacillus casei, contains over 50 billion living bacteria per administered dose.

Placebo

Intervention Type OTHER

Placebo is devoid of microorganisms.

Interventions

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BIO-K+ CL-1285®

A mixture of Lactobacillus acidophilus and Lactobacillus casei, contains over 50 billion living bacteria per administered dose.

Intervention Type OTHER

Placebo

Placebo is devoid of microorganisms.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

50 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes