Clinical trial NCT00958308: 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
Official title: A Double-blind, Randomized, Placebo-controlled, Single-center Study of the Efficacy and Safety of BIO-K+ CL-1285® in the Prevention of Antibiotic-Associated Diarrhea (AAD) and Clostridium Difficile-Associated Diarrhea (CDAD) in Hospitalized Adult Patients Exposed to Nosocomial Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Antibiotic-Associated Diarrhea
Clostridium Difficile-Associated Diarrhea
Keywords: Probiotic
Antibiotic-Associated Diarrhea (AAD) Prevention
Clostridium Difficile-Associated Diarrhea (CDAD)Prevention
Lead sponsor: Bio-K Plus International Inc.
Sponsor class: INDUSTRY
Collaborators: name: Sprim Advanced Life Sciences
First posted: 2009-08-13
Enrollment: 255
Sex: ALL
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 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

Primary outcomes:
measure: To Assess if Probiotic Prophylaxis (BIO-K+CL1285®) is Effective for the Prevention of AAD in Hospitalized Patients.
timeFrame: Up to 40 days
Secondary outcomes:
measure: Severity of AAD in Hospitalized Patients Ingesting BIO-K+CL1285® or Placebo.
timeFrame: Up to 40 days
measure: Frequency of Stool Samples Positive for Clostridium Difficile (C. Difficile) Toxin A and/or B.
timeFrame: Up to 40 days
measure: Safety Profile of BIO-K+CL1285® Versus Placebo in Hospitalized Patients.
timeFrame: Up to 40 days
measure: Frequencies of Other Gastrointestinal Symptoms.
timeFrame: Up to 40 days
Other outcomes:
Locations:
Study officials:
affiliation: Xinhua/Yuyao Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
name: Gao XingWang, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gao XW, Mubasher M, Fang CY, Reifer C, Miller LE. Dose-response efficacy of a proprietary probiotic formula of Lactobacillus acidophilus CL1285 and Lactobacillus casei LBC80R for antibiotic-associated diarrhea and Clostridium difficile-associated diarrhea prophylaxis in adult patients. Am J Gastroenterol. 2010 Jul;105(7):1636-41. doi: 10.1038/ajg.2010.11. Epub 2010 Feb 9.