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Evaluation of the Efficacy of Bio-K+ Cl-1285® In the Nasal Decolonization of Methicillin Resistant Staphylococcus Aureus (MRSA) Carrier Patients

This study has been terminated.
(Unable to recruit patients to continue on with the study.)
Sponsor:
Collaborator:
Centre Hospitalier Pierre-Le Gardeur
Information provided by:
Bio-K Plus International Inc.
ClinicalTrials.gov Identifier:
NCT00941356
First received: January 15, 2009
Last updated: August 31, 2010
Last verified: August 2010

January 15, 2009
August 31, 2010
January 2010
August 2010   (final data collection date for primary outcome measure)
Frequency of subjects with MRSA decolonization [ Time Frame: 21 days ] [ Designated as safety issue: No ]
nasal decolonisation after use of the study product [ Time Frame: 21 days ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00941356 on ClinicalTrials.gov Archive Site
To evaluate the secondary effects (incidence rate of non-serious ans serious adverse events)associated to the administration of the study product [ Time Frame: 21 days ] [ Designated as safety issue: Yes ]
To evaluate the secondary effects associated to the administration of the study product [ Time Frame: 21 days ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Evaluation of the Efficacy of Bio-K+ Cl-1285® In the Nasal Decolonization of Methicillin Resistant Staphylococcus Aureus (MRSA) Carrier Patients
A Single Center, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Efficacy of Bio-K+ Cl-1285® In the Nasal Decolonization of Methicillin Resistant Staphylococcus Aureus (MRSA) Carrier Patients

Trial Objectives:

Primary objective:

  • To evaluate the efficacy of Bio-K+CL1285® in patients with Methicillin-Resistant S. aureus (MRSA) nasal colonization by comparing the MRSA decolonization following either Bio-K+CL1285® or placebo treatment.

Secondary objective:

  • To evaluate the safety profile of Bio-K+CL1285®.

Study Design:

Double-blind, randomized (1:1 randomization), placebo-controlled, single center Canadian study.

Patients will be randomly assigned to one of the two study products. A randomization schedule will be generated by the sponsor for each participating centre. This schedule will link patient identification numbers to one of the two study products allocated at random. The schedule will be prepared on a 1:1 randomization ratio.

The study products will be labelled with the patient identification number. Patients have to be randomized in the order in which they qualify from the screening phase for inclusion in the study.

Patients withdrawn from the study retain their patient number if already given. New patients must always be allotted a new identification number (PIN).

Study Duration:

The duration of patient participation in the study will be between 22 and 23 days. The overall duration of the study is expected to be approximately 10 months; with subject recruitment proposed to start in March 2009, the last follow-up visit is expected in May 2010. The actual overall study duration or subject recruitment period may vary.

Number of Sites (inside and outside of Canada):

One center in the province of Quebec will be involved in the study.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
MRSA Colonization
  • Dietary Supplement: Bio-K+ CL1285
    2 capsules per day before breakfast
    Other Name: Bio-K+ CL1285(R) Extra Strength
  • Dietary Supplement: Placebo
    2 capsules per day before breakfast
  • Experimental: 1
    Bio-K+ CL1285 contains 50 billion of live bacteria
    Intervention: Dietary Supplement: Bio-K+ CL1285
  • 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.
 
Terminated
146
August 2010
August 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male or female patients having ≥18 years of age
  • Women of child bearing capacity who are not pregnant at the moment of screening (Pregnancy test done on-site) and agree to use an acceptable form of birth control for the duration of the study (e.g. condom, oral contraceptives, etc.) are allowed to participate.
  • Patients must have nasal MRSA colonization confirmed with MRSA positive culture as assessed during the screening visit without any clinical signs or symptoms of infection.
  • Laboratory test results within the normal ranges.
  • Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

  • Patients treated for nasal MRSA decolonization in the last 6 months;
  • Current infection with MRSA;
  • Ongoing or active infection;
  • Daily probiotic/ fermented milk or Yogurt use;
  • Known to have shown a previous reaction, including anaphylaxis, to any substance in composition of the study agent (capsules);
  • Ongoing or recent use of antibiotics in the 30 days prior to the study agent administration;
  • Pregnancy, breastfeeding;
  • Regular use of nasal agents;
  • Uncontrolled intercurrent illness, including situations that would limit compliance with study requirements;
  • Patients with open wounds
  • Immunosuppressive therapy or any health condition causing inmunosuppression (Including Haematological malignancies, AIDS);
  • Ostomized patients, parenteral nutrition users;
  • Patients with current vascular access (catheter) or planned to have installed a vascular access (catheter) or any prosthesis during the study period.
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00941356
CL1285-MRSA-M03
No
Dr Pierre-Jean Maziade, Microbiologist, Pierre Le Gardeur Hospital
Bio-K Plus International Inc.
Centre Hospitalier Pierre-Le Gardeur
Principal Investigator: Dr Pierre-Jean PM Maziade, MD Pierre Le Gardeur Hospital
Bio-K Plus International Inc.
August 2010

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