Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2025-12-24 @ 11:38 PM
NCT ID:
NCT00941356
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT00941356
Study Brief:
Protocol Section:
NCT00941356