Kamil Janeczek1, Andrzej Emeryk2, Marta Rachel3, Dariusz Duma4, Łukasz Zimmer5, Ewa Poleszak5. 1. Department of Pulmonary Diseases and Children Rheumatology, Medical University of Lublin, Lublin, Poland. Electronic address: kamil.janeczek@umlub.pl. 2. Department of Pulmonary Diseases and Children Rheumatology, Medical University of Lublin, Lublin, Poland. 3. Chair and Department of Human Physiology and Pathophysiology, University of Rzeszów, Rzeszów, Poland. 4. Department of Laboratory Diagnostics, Medical University of Lublin, Lublin, Poland. 5. Department of Applied and Social Pharmacy, Medical University of Lublin, Lublin, Poland.
Abstract
BACKGROUND: Recent studies highlight the immunoregulatory potential of bacterial lysates, indicating their potential use in the prevention and treatment of allergic diseases. OBJECTIVE: To investigate the clinical efficacy of polyvalent mechanical bacterial lysates (PMBLs) in children with grass pollen-induced allergic rhinitis. METHODS:Seventy children with seasonal allergic rhinitis were enrolled to this study and were randomly assigned to the PMBL and placebo groups. Severity of seasonal allergic rhinitis symptoms was assessed by the total nasal symptom score, total ocular symptom score, and visual analogue scale. During 3 visits, peak nasal inspiratory flow was measured, and nasal smears for the presence of eosinophils and nasal lavage fluids for the presence of allergen-specific IgE against timothy grass pollen allergens were sampled. RESULTS: A statistically significant decrease in total nasal symptom score (P = .001), total ocular symptom score (P = .04), and visual analogue scale score for nasal and eye symptoms (P < .001 and P < .001, respectively) and an increase in peak nasal inspiratory flow (P = .04) were observed in the PMBL group versus the placebo group. During the grass pollen season, an increase and then a decrease in the number of eosinophils in nasal smears was observed in both groups; however, the number of eosinophils was significantly lower in the PMBL group versus the placebo group. No significant changes in allergen-specific IgE concentrations were observed in the PMBL group, whereas in the placebo group a statistically significant increase in allergen-specific IgE concentration was observed. CONCLUSIONS: Sublingual administration of PMBLs during the grass pollen season offers significant efficacy in alleviating seasonal allergic rhinitis symptoms in children sensitized to grass pollen allergens. PMBLs probably affect mucosal immunity, weakening the response of TH2 cells.
RCT Entities:
BACKGROUND: Recent studies highlight the immunoregulatory potential of bacterial lysates, indicating their potential use in the prevention and treatment of allergic diseases. OBJECTIVE: To investigate the clinical efficacy of polyvalent mechanical bacterial lysates (PMBLs) in children with grass pollen-induced allergic rhinitis. METHODS: Seventy children with seasonal allergic rhinitis were enrolled to this study and were randomly assigned to the PMBL and placebo groups. Severity of seasonal allergic rhinitis symptoms was assessed by the total nasal symptom score, total ocular symptom score, and visual analogue scale. During 3 visits, peak nasal inspiratory flow was measured, and nasal smears for the presence of eosinophils and nasal lavage fluids for the presence of allergen-specific IgE against timothy grass pollen allergens were sampled. RESULTS: A statistically significant decrease in total nasal symptom score (P = .001), total ocular symptom score (P = .04), and visual analogue scale score for nasal and eye symptoms (P < .001 and P < .001, respectively) and an increase in peak nasal inspiratory flow (P = .04) were observed in the PMBL group versus the placebo group. During the grass pollen season, an increase and then a decrease in the number of eosinophils in nasal smears was observed in both groups; however, the number of eosinophils was significantly lower in the PMBL group versus the placebo group. No significant changes in allergen-specific IgE concentrations were observed in the PMBL group, whereas in the placebo group a statistically significant increase in allergen-specific IgE concentration was observed. CONCLUSIONS: Sublingual administration of PMBLs during the grass pollen season offers significant efficacy in alleviating seasonal allergic rhinitis symptoms in children sensitized to grass pollen allergens. PMBLs probably affect mucosal immunity, weakening the response of TH2 cells.
Authors: Geertje M de Boer; Gert-Jan Braunstahl; Esmee K van der Ploeg; Cathelijne M van Zelst; Alie van Bruggen; Guido Epping; Menno van Nimwegen; Gert Verhoeven; Erwin Birnie; Bianca M Boxma-de Klerk; Marjolein J W de Bruijn; Ralph Stadhouders; Rudi W Hendriks; Gerdien A Tramper-Stranders Journal: Clin Exp Allergy Date: 2021-08-06 Impact factor: 5.401