Effect of Bacterial Lysate on Nasal Carriage of Staphylococcus Aureus

• Status: Completed
• Trial end date: 2020-08-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medical University of Lublin
• Treatments: Broncho-Vaxom

Criteria

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.