Back to resultsEvaluation of the Efficacy of Bio-K+ Cl-1285® In the Nasal Decolonization of Methicillin Resistant Staphylococcus Aureus (MRSA) Carrier Patients (MRSA)
Primary Purpose
MRSA Colonization
Status
Withdrawn
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Bio-K+ CL1285
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for MRSA Colonization focused on measuring MRSA nasal colonisation, Probiotics
Eligibility 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.
Sites / Locations
- Pierre Le Gardeur Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
Bio-K+ CL1285 contains 50 billion of live bacteria
placebo devoid of bacteria
Outcomes
Primary Outcome Measures
Frequency of subjects with MRSA decolonization
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
Full Information
NCT ID
NCT00941356
First Posted
January 15, 2009
Last Updated
July 21, 2022
Sponsor
Bio-K Plus International Inc.
Collaborators
Centre Hospitalier Pierre-Le Gardeur
1. Study Identification
Unique Protocol Identification Number
NCT00941356
Brief Title
Evaluation of the Efficacy of Bio-K+ Cl-1285® In the Nasal Decolonization of Methicillin Resistant Staphylococcus Aureus (MRSA) Carrier Patients
Acronym
MRSA
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Withdrawn
Why Stopped
Unable to recruit patients to continue on with the study.
Study Start Date
January 2010 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
July 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bio-K Plus International Inc.
Collaborators
Centre Hospitalier Pierre-Le Gardeur
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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®.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
MRSA Colonization
Keywords
MRSA nasal colonisation, Probiotics
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Bio-K+ CL1285 contains 50 billion of live bacteria
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
placebo devoid of bacteria
Intervention Type
Dietary Supplement
Intervention Name(s)
Bio-K+ CL1285
Other Intervention Name(s)
Bio-K+ CL1285(R) Extra Strength
Intervention Description
2 capsules per day before breakfast
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
2 capsules per day before breakfast
Primary Outcome Measure Information:
Title
Frequency of subjects with MRSA decolonization
Time Frame
21 days
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr Pierre-Jean PM Maziade, MD
Organizational Affiliation
Pierre Le Gardeur Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pierre Le Gardeur Hospital
City
Terrebonne
State/Province
Quebec
ZIP/Postal Code
J6V 2H2
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Evaluation of the Efficacy of Bio-K+ Cl-1285® In the Nasal Decolonization of Methicillin Resistant Staphylococcus Aureus (MRSA) Carrier Patients
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