Effect of Bacterial Lysate on Nasal Carriage of Staphylococcus Aureus
Condition: Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic
Study type: Interventional
Phase: Phase 3

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.
    

Detailed description: 
      Seasonal allergic rhinitis (SAR) is caused by the allergens of wind-pollinated plants, and in
      Poland mainly by grass pollen allergens. During the grass pollen season, patients may suffer
      from fatigue, weakness, lack of fitness, difficulty in sleeping and reduced performance at
      school. In people allergic to the above-mentioned pollen, the disease significantly reduces
      the quality of life and requires intensive treatment in the pollen period.

      MRSA colonizing the nasal cavity has the ability to actively modulate the immune response in
      children suffering from SAR. Many studies have shown a greater severity of AR symptoms in
      patients with a MRSA-positive nasal swab compared to patients with normal nasal flora.

      Due to the high incidence of AR, the negative impact of the disease on the quality of life,
      and incomplete effectiveness of previously available therapeutic methods, new methods of
      treatment are being developed. Recent research highlights the immunoregulatory potential of
      bacterial lysates, indicating the possibility of their future use in the prevention and
      treatment of allergic diseases, including atopic dermatitis, AR, and asthma.

      Based on the above considerations, it can be hypothesized that bacterial lysates reduce the
      severity of AR symptoms by eradicating MRSA from the nasal cavity. However, so far no
      randomized, double-blind, placebo-controlled study has been conducted to evaluate the effect
      of bacterial lysates on nasal Staphylococcus aureus carriage in children with SAR.

      The main aim of this study was to evaluate nasal colonization by MRSA among children with SAR
      and the effect of PMBL on the reduction of MRSA colony growth in these children.

      70 children with SAR were enrolled to this study and were randomly assigned to the PMBL group
      (n=35) and placebo group (n=35). Two visits took place as part of the study: at the beginning
      of the grass pollen season and at the end of the season. The time frame of the grass pollen
      season for south-eastern Poland was determined using the "95%" method on the basis of
      measurements of grass pollen concentration in the atmospheric air, which were obtained from
      the Environmental Allergy Research Centre in Warsaw. Nasal swabs for bacteriological cultures
      were taken at each visit and were transferred to the hospital laboratory.
    

Intervention name(s): Ismigen; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Sublingual tablets containing 7 mg of bacterial lysate from the following bacteria: Staphylococcus aureus, Haemophilus influenzae serotype B, Klebsiella pneumoniae, Klebsiella ozaenae, Neiserria catarrhalis, Streptococcus viridans, Streptococcus pyogenes, Streptococcus pneumoniae (6 strains: TY1/EQ11, TY2/EQ22, TY3/EQ14, TY5/EQ15, TY8/EQ23, TY47/EQ24) - sublingual use 1 tablet per day over 10 days for 3 successive months.; Matched tablets without any active substance.
Other intervention name(s): Polyvalent Mechanical Bacterial Lysate (PMBL)
Intervention MeSH terms: Broncho-Vaxom
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: allergic rhinitis; seasonal allergic rhinitis; children; grass pollen season; bacterial lysate; nasal Staphylococcus aureus carriage