Evaluation of the Efficacy of Bio-K+ Cl-1285® In the Nasal Decolonization of Methicillin Resistan… (NCT00941356) | Clinical Trial Compass
WithdrawnPhase 2
Evaluation of the Efficacy of Bio-K+ Cl-1285® In the Nasal Decolonization of Methicillin Resistant Staphylococcus Aureus (MRSA) Carrier Patients
Stopped: Unable to recruit patients to continue on with the study.
Canada0Started 2010-01
Plain-language 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®.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.