Status:
COMPLETED
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
Lead Sponsor:
Bio-K Plus International Inc.
Collaborating Sponsors:
Sprim Advanced Life Sciences
Conditions:
Antibiotic-Associated Diarrhea
Clostridium Difficile-Associated Diarrhea
Eligibility:
All Genders
50-70 years
Phase:
PHASE3
Brief 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 hosp...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2009
Estimated Enrollment :
255 Patients enrolled
Trial Details
Trial ID
NCT00958308
Start Date
December 1 2008
End Date
April 1 2009
Last Update
March 13 2012
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