The aim of the study is to assess the effect of polyvalent mechanical bacterial lysate (PMBL, Ismigen) on the clinical course of grass pollen-induced allergic rhinitis (using: total nasal symptom score, visual analogue scale, peak nasal inspiratory flow measurement) in children aged 5 to 17 and to assess changes in the concentration of iNKT cells under the influence of the therapy. Half of the 80 participants will receive PMBL while the other half will receive placebo.
Age range
5 Years – 17 Years
Sex
ALL
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A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Change in the severity of nasal SAR symptoms as assessed by total nasal symptom score (TNSS)
Timeframe: at baseline, at 1-month, at 2-months, at 3-months, at 4-months and at 5-months
Change in the nasal obstruction using peak nasal inspiratory flow (PNIF)
Timeframe: at baseline and at 3-months
Change in the severity of nasal SAR symptoms as assessed by visual analogue scale (VAS)
Timeframe: at baseline, at 1-month, at 2-months, at 3-months, at 4-months and at 5-months
iNKT1 cells concentration
Timeframe: at baseline and at 3-months
iNKT2 cells concentration
Timeframe: at baseline and at 3-months
iNKT10 cells concentration
Timeframe: at baseline and at 3-months
iNKT17 cells concentration
Timeframe: at baseline and at 3-months
iNKTreg cells concentration
Timeframe: at baseline and at 3-months