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
  Purpose

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.


Condition Intervention Phase
Diarrhea
Clostridium Infections
Dietary Supplement: Lactobacillus acidophilus CL1285 and Lactobacillus casei
Dietary Supplement: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by Bio-K Plus International Inc.:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Enrollment: 472
Study Start Date: March 2006
Study Completion Date: October 2007
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Bio-K Cl1285 Bio-K Cl1285 contains 50 billion of live bacteria.
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
Placebo Comparator: 2
placebo devoid of bacteria
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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00328263

Locations
Canada, Ontario
Hamilton General Hospital
Hamilton, Ontario, Canada, L8L-2X2
Kingston General Hospital
Kingston, Ontario, Canada, K7L 2V7
North York General Hospital
Toronto, Ontario, Canada, M2K 1E1
Canada, Quebec
Hotel Dieu de Chicoutimi
Chicoutimi, Quebec, Canada, G7H5H6
St-Mary Hospital Center
Montreal, Quebec, Canada, H3T 1M5
Hotel-Dieu de St-Jerome
St-Jerome, Quebec, Canada, J7Z 5T3
Centre Hospitalier Régional de Trois-Rivières
Trois-Rivieres, Quebec, Canada, G8Z 3R9
Canada
Laval Hospital
Quebec, Canada, G1V 4G5
Sponsors and Collaborators
Bio-K Plus International Inc.
JSS Medical Research Inc.
Investigators
Principal Investigator: Joe S Dylewski, MD St-Mary Hospital Center
  More Information

No publications provided

Responsible Party: Bio-K Plus International Inc.
ClinicalTrials.gov Identifier: NCT00328263     History of Changes
Other Study ID Numbers: CL1285-AAD-M01
Study First Received: May 17, 2006
Results First Received: August 28, 2012
Last Updated: July 15, 2014
Health Authority: Canada: Health Canada

Keywords provided by Bio-K Plus International Inc.:
Bio-K+CL1285
Probiotics
Antibiotics-associated diarrhea
Clostridium difficile-associated diarrhea
Lactobacillus acidophilus
Clostridium Difficile

Additional relevant MeSH terms:
Diarrhea
Clostridium Infections
Communicable Diseases
Infection
Bacterial Infections
Gram-Positive Bacterial Infections
Signs and Symptoms
Signs and Symptoms, Digestive
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014