Efficacy and Safety of BIO-K + CL1285 in Prevention of Antibiotic-associated Diarrhea in Hospitalized Adult Patients

This study has been completed.
Sponsor:
Collaborator:
JSS Medical Research Inc.
Information provided by (Responsible Party):
Bio-K Plus International Inc.
ClinicalTrials.gov Identifier:
NCT00328263
First received: May 17, 2006
Last updated: July 15, 2014
Last verified: July 2014

May 17, 2006
July 15, 2014
March 2006
March 2007   (final data collection date for primary outcome measure)
The Incidence of Antibiotic-associated Diarrhea. [ Time Frame: Up to 40 days ] [ Designated as safety issue: No ]
Presence of at least one diarrhea episode within 24 hours.
  • Efficacy of the product will evaluate the severity of AAD, i.e., the presence of blood in the feces, fever, average number of liquid stools per day and duration of diarrhea during the episode of AAD.
  • Efficacy of the product will evaluate the incidence of antibiotic-associated diarrhea (AAD), i.e., the presence of more than one liquid stool/24 hour period
Complete list of historical versions of study NCT00328263 on ClinicalTrials.gov Archive Site
  • Positive Results for Clostridium Difficile (C. Difficile) Toxin A or B in Antibiotic Associated Diarrhea Patients. [ Time Frame: Up to 40 days ] [ Designated as safety issue: No ]
    Testing for CDAD was performed at the discretion of the treating physician and according to the protocol in place at the study centers. CDAD was defined as an episode of diarrhea and positive results for C. difficile Toxin A or B.
  • Health Outcome Evaluation Will Look at the Direct Medical Costs and Clinical Outcomes of Alternative Strategies in the Prevention of Antibiotic-associated Diarrhea in Hospitalized Adult Patients [ Time Frame: Up to 40 days ] [ Designated as safety issue: No ]
  • Safety Profile of BIO-K+CL1285® Versus Placebo in Patients on Antibiotics [ Time Frame: Up to 40 days ] [ Designated as safety issue: Yes ]
    Safety was assessed by the incidence of treatment-emerged adverse events, which were reported according to MedDRA 10.1
  • Efficacy of the product will evaluate the incidence of Clostridium difficile-associated diarrhea, i.e, the stool from patients presenting with AAD will be tested for the presence of Clostridium difficile(Triage, toxin A and B or cytotoxicity)
  • Health outcome evaluation will look at the direct medical costs and clinical outcomes of alternative strategies in the prevention of antibiotic-associated diarrhea in hospitalized adult patients.
  • Safety will be evaluated on the basis of serious and non-serious adverse events.
Not Provided
Not Provided
 
Efficacy and Safety of BIO-K + CL1285 in Prevention of Antibiotic-associated Diarrhea in Hospitalized Adult Patients
A Double-blind, Randomized, Placebo Controlled, Multicenter Study of the Efficacy and Safety of BIO-K*+ CL-1285* in the Prevention of Antibiotic-associated Diarrhea in Adult Patients Exposed to Nosocomial Infection.

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.

Antibiotic-associated diarrhea (AAD) is one of the most frequent adverse events following antibiotherapy and is the leading cause of diarrhea in hospitalized patients. Ten to 25% of AAD are caused by the bacteria Clostridium difficile.

A recent unicenter study conducted at Maisonneuve-Rosemont hospital demonstrated the preventive role of Bio-K + CL1285 in antibiotic-associated diarrhea and Clostridium difficile-associated diarrhea. Its preventive role is thought to be mainly through restoration of the gastrointestinal flora affected in part by the antibiotherapy.

A wide body of literature reveals clinical use of probiotics, but few well controlled prospective studies conducted on large numbers of subjects have been performed.

In light of the positive preliminary results obtained in a limited number of patients with AAD and of the paucity of well controlled clinical trials, we now wish to undertake a randomized, double blind, multicentre study to evaluate the efficacy and safety of Bio-K + CL1285 prophylaxis vs. placebo in the prevention of antibiotic-associated diarrhea in hospitalized adult patients. As secondary objectives, we also intend to evaluate the incidence of Clostridium difficile-associated diarrhea and to demonstrate that BIO-K + CL1285 agent will not only improve the clinical outcomes but also reduce health care expenditures.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
  • Diarrhea
  • Clostridium Infections
  • Dietary Supplement: Lactobacillus acidophilus CL1285 and Lactobacillus casei
    One bottle daily 2 hours before or after antibiotic administration and for 5 days following the termination of antibiotic regimen.
    Other Name: BioK CL1285
  • Dietary Supplement: placebo
    One bottle daily 2 hours before or after antibiotic administration and for 5 days following the termination of antibiotic regimen.
    Other Name: placebo
  • Experimental: 1
    Bio-K Cl1285 Bio-K Cl1285 contains 50 billion of live bacteria.
    Intervention: Dietary Supplement: Lactobacillus acidophilus CL1285 and Lactobacillus casei
  • Placebo Comparator: 2
    placebo devoid of bacteria
    Intervention: Dietary Supplement: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
472
October 2007
March 2007   (final data collection date for primary outcome measure)

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.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00328263
CL1285-AAD-M01
Yes
Bio-K Plus International Inc.
Bio-K Plus International Inc.
JSS Medical Research Inc.
Principal Investigator: Joe S Dylewski, MD St-Mary Hospital Center
Bio-K Plus International Inc.
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP