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
  Purpose

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®.

Condition Intervention Phase
MRSA Colonization
Dietary Supplement: Bio-K+ CL1285
Dietary Supplement: Placebo
Phase 2

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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Frequency of subjects with MRSA decolonization [ Time Frame: 21 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 146
Study Start Date: January 2010
Estimated Study Completion Date: August 2010
Estimated Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Bio-K+ CL1285 contains 50 billion of live bacteria
Dietary Supplement: Bio-K+ CL1285
2 capsules per day before breakfast
Other Name: Bio-K+ CL1285(R) Extra Strength
Placebo Comparator: 2
placebo devoid of bacteria
Dietary Supplement: Placebo
2 capsules per day before breakfast

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  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: NCT00941356

Locations
Canada, Quebec
Pierre Le Gardeur Hospital
Terrebonne, Quebec, Canada, J6V 2H2
Sponsors and Collaborators
Bio-K Plus International Inc.
Centre Hospitalier Pierre-Le Gardeur
Investigators
Principal Investigator: Dr Pierre-Jean PM Maziade, MD Pierre Le Gardeur Hospital
  More Information

No publications provided

Responsible Party: Dr Pierre-Jean Maziade, Microbiologist, Pierre Le Gardeur Hospital
ClinicalTrials.gov Identifier: NCT00941356     History of Changes
Other Study ID Numbers: CL1285-MRSA-M03
Study First Received: January 15, 2009
Last Updated: August 31, 2010
Health Authority: Canada: Health Canada

Keywords provided by Bio-K Plus International Inc.:
MRSA nasal colonisation
Probiotics

Additional relevant MeSH terms:
Staphylococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on October 16, 2014