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

Bio-K Plus

Status and phase: Completed; Phase 3

Conditions: Clostridium Difficile-Associated Diarrhea; Antibiotic-Associated Diarrhea

Treatments: Other: Placebo; Other: BIO-K+ CL-1285®

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00958308

CL 1285-AAD-CH01

07-SC-9-BIK-01

Details and patient eligibility

About

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.

Enrollment: 255 patients

Sex: All

Ages: 50 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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255 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Other: Placebo

BIO-K+ CL-1285

Active Comparator group

Description:

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.

Treatment:

Other: BIO-K+ CL-1285®

BIO-K+ CL-1285® & placebo

Other group

Description:

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.

Treatment:

Other: BIO-K+ CL-1285®

Other: Placebo