Efficacy and Safety of BIO-K + CL1285 in Prevention of Antibiotic-Associated Diarrhea in Hospitalized Adult Patients - Full Text View

Sponsored by:	Bio-K Plus International Inc.
Information provided by:	Bio-K Plus International Inc.
ClinicalTrials.gov Identifier:	NCT00328263

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 III

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
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:

MedlinePlus related topics: Antibiotics Diarrhea Dietary Supplements Diets

Drug Information available for: Lactobacillus casei Lactobacillus acidophilus

U.S. FDA Resources

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

Primary Outcome Measures:

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 the duration of diarrhea during the episode of AAD. [ Time Frame: March 2006-December 2007 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Efficacy of the product will evaluate the incidence of Clostridium difficile in antibiotic associated diarrhea patients [ Time Frame: March 2006- December 2007 ] [ Designated as safety issue: No ]
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: March 2006- December 2007 ] [ Designated as safety issue: No ]
Safety will be evaluated on the basis of serious and non-serious adverse events. [ Time Frame: March 2006- December 2007 ] [ Designated as safety issue: Yes ]

Enrollment:	480
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
1: Experimental 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
2: Placebo Comparator placebo devoid of bacteria	Dietary Supplement: placebo one bottle daily 2 hours before or after antibiotic adminiatration

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 yogourt;
intolerance to lactose;
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 yogourt consumption during the study period and two consecutive missed dose of study product.

Contacts and Locations

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

Locations

Canada
Laval Hospital
Quebec, Canada, G1V 4G5
Canada, Ontario
Hamilton General Hospital
Hamilton, Ontario, Canada, L8L-2X2
North York General Hospital
Toronto, Ontario, Canada, M2K 1E1
Kingston General Hospital
Kingston, Ontario, Canada, K7L 2V7
Canada, Quebec
Hotel Dieu de Chicoutimi
chicoutimi, Quebec, Canada, G7H5H6
Centre Hospitalier Régional de Trois-Rivières
Trois-Rivieres, Quebec, Canada, G8Z 3R9
Hotel-Dieu de St-Jerome
St-Jerome, Quebec, Canada, J7Z 5T3
St-Mary Hospital Center
Montreal, Quebec, Canada, H3T 1M5

Sponsors and Collaborators

Bio-K Plus International Inc.

Investigators

Principal Investigator:

Joe S Dylewski, MD

St-Mary Hospital Center

More Information

No publications provided

Responsible Party:	Microbiologist at St Mary's Hospital ( Dr Joe Dylewski )
Study ID Numbers:	CL1285-AAD-M01
Study First Received:	May 17, 2006
Last Updated:	September 17, 2008
ClinicalTrials.gov Identifier:	NCT00328263 History of Changes
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

Study placed in the following topic categories:

Bacterial Infections
Anti-Infective Agents
Anti-Bacterial Agents
Signs and Symptoms
Gram-Positive Bacterial Infections

Diarrhea
Signs and Symptoms, Digestive
Clostridium Difficile
Acidophilus
Clostridium Infections

Additional relevant MeSH terms:

Bacterial Infections
Anti-Infective Agents
Anti-Bacterial Agents
Signs and Symptoms
Communicable Diseases
Gram-Positive Bacterial Infections

Diarrhea
Signs and Symptoms, Digestive
Therapeutic Uses
Infection
Clostridium Infections
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 11, 2009