MRSA ColonizationPhase 2MRSANCT00941356
Evaluation of the Efficacy of Bio-K+ Cl-1285® In the Nasal Decolonization of Methicillin Resistant Staphylococcus Aureus (MRSA) Carrier Patients
A Phase 2 study testing Bio-K+ CL1285 in people with MRSA Colonization, run by Bio-K Plus International Inc. at 1 site in Canada.
Trial 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®. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- MRSA Colonization
- What is being tested?
- Bio-K+ CL1285
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2010to Jul 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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®.
Read the 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.
- Conditions
- MRSA Colonization
- Being tested
- Bio-K+ CL1285, Placebo
- Keywords
- MRSA nasal colonisation, Probiotics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bio-K+ CL1285Dietary supplement
Also called Bio-K+ CL1285(R) Extra Strength
2 capsules per day before breakfast
PlaceboDietary supplement
2 capsules per day before breakfast
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Bio-K+ CL1285 contains 50 billion of live bacteria Receives: Dietary Supplement: Bio-K+ CL1285 |
| 2 | Placebo comparator | placebo devoid of bacteria Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of subjects with MRSA decolonization
Measured: 21 days
Secondary outcomes (1)
To evaluate the secondary effects (incidence rate of non-serious ans serious adverse events)associated to the administration of the study product
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2009 (estimated)
- Study startJan 2010
- Primary completionJul 2016
- Study completionJul 2016
Why it stopped: Unable to recruit patients to continue on with the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MRSA ColonizationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bio-K Plus International Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Centre Hospitalier Pierre-Le Gardeur
- Responsible party
- Sponsor
- Investigators
- Dr Pierre-Jean PM Maziade, MD, Principal investigator, Pierre Le Gardeur Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00941356
- Sponsor's protocol ID
- CL1285-MRSA-M03
- Acronym
- MRSA
- Status last verified
- Jul 2022
- First submitted
- 15 Jan 2009
- Last updated
- 22 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00941356
- Acronym / sponsor ID
- MRSA / CL1285-MRSA-M03
- Conditions
- MRSA Colonization
- Keywords
- MRSA nasal colonisation, Probiotics
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Unable to recruit patients to continue on with the study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Bio-K Plus International Inc.Industry (pharma, biotech, devices)
- Collaborators
- Centre Hospitalier Pierre-Le Gardeur
- Study start
- Jan 2010
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 17 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Dietary Supplement: Bio-K+ CL1285Bio-K+ CL1285 contains 50 billion of live bacteria |
| 2 | Placebo comparator | Dietary Supplement: Placeboplacebo devoid of bacteria |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (13 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bio-K+ CL1285Also: Bio-K+ CL1285(R) Extra Strength2 capsules per day before breakfast | Dietary supplement | 1 |
| Placebo2 capsules per day before breakfast | Dietary supplement | 2 |
Primary outcome
Frequency of subjects with MRSA decolonization
Time frame: 21 days
1 secondary outcome
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr Pierre-Jean PM Maziade, MD principal investigator
Pierre Le Gardeur Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bio-K+ CL1285 in people with MRSA Colonization, run by Bio-K Plus International Inc. at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 22 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of subjects with MRSA decolonization (time frame: 21 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2022.