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.
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.
What they're measuring
1
Change in the growth intensity of the nasal Staphylococcus aureus colony