Effect of Bacterial Lysate on Nasal Carriage of Staphylococcus Aureus (NCT04637425) | Clinical Trial Compass
CompletedPhase 3
Effect of Bacterial Lysate on Nasal Carriage of Staphylococcus Aureus
Poland70 participantsStarted 2018-04-22
Plain-language summary
This study assesses the effectiveness of Polyvalent Mechanical Bacterial Lysate (PMBL-Ismigen) in reducing nasal methicillin-resistant Staphylococcus aureus (MRSA) colony growth in children with pollen allergic rhinitis (AR) aged 5 to 17. Half of the participants received PMBL and the other half received a placebo.
Who can participate
Age range
5 Years – 17 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:
* Children of both genders aged 5 to 17 years.
* Children with grass pollen-induced allergic rhinitis recognized and treated according to current ARIA (Allergic Rhinitis and its Impact on Asthma) recommendations.
* Positive skin prick test to grass pollen allergens or positive specific IgE (defined as ≥ class 2, ≥ 0,70 kU/l) against timothy grass pollen allergens.
* Presentation of clinical symptoms of the allergic rhinitis (rhinorrhea, nasal congestion, nasal itching, sneezing) in at least two recent grass pollen seasons in Poland before inclusion in the study.
* Proper use of polyvalent mechanical bacterial lysate sublingual tablets.
* Written informed consent obtained from parents/guardians before any study related procedures are performed.
Exclusion Criteria:
* Patient received mechanical or any other polyvalent bacterial lysate immunostimulation within the previous 12 months before randomisation visit.
* Patient received oral/subcutaneous allergen-immunotherapy within the previous 3 years before the start of the study.
* Vaccination performed within 3 months before the beginning of the study.
* Deficiencies in cellular and humoral immunity.
* Treatment with antibiotics within the last 1 month before the start of the study.
* Treatment with systemic corticosteroids within the last 6 months before the start of the study.
* Pregnant or breastfeeding woman.
* Other chronic conditions of the nose or nasal sinuses.
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.
1This trial used a bacterial lysate to try to reduce Staphylococcus aureus growth in the nose of people with allergic rhinitis — could my doctor explain whether carrying S. aureus in my nose is something we should actually be concerned about in my case?
2Since this was a Phase 3 trial that has already completed, has the results data been published yet, and what did it show about how well the bacterial lysate actually reduced S. aureus nasal carriage?
3Bacterial lysates are sometimes used to help with immune responses in allergic conditions — is this type of treatment something my doctor would consider relevant to my allergic rhinitis, or are there more established options I should try first?
4Because the trial is completed but I'm not currently enrolled, what would my doctor recommend now if we found that S. aureus nasal carriage might be contributing to my allergy symptoms — are there existing approved treatments that work similarly?
5How does the presence of S. aureus in the nose relate to allergic rhinitis symptoms specifically, and is testing for nasal S. aureus carriage something my doctor thinks would be worthwhile in my situation?
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.
What they're measuring
1
Change in the growth intensity of the nasal Staphylococcus aureus colony