Clinical and immunological efficacy of bacterial lysate OM-85 in children with respiratory tract infection

T.V. Sorokman, P.M. Moldovan, N.O. Popeluk, D.I. Kolesnik, І.S. Sokolnyk


Background. According to current epidemiological data, frequent respiratory infections occupy a leading position in the structure of childhood morbidity in Ukraine. The program of comprehensive children rehabilitation includes immune rehabilitation as the main measurement. Materials and methods. One-hundred and eight children aged from 1 to 3 years were diagnosed with an acute respiratory infection (АRI): the first group consisted of 57 children receiving standard therapy according to the current guidelines, the second group consisted of 51 children whose therapy was added with the drug OM-85 at a dosage of 3.5 mg per day. The levels of T-lymphocytes, T-helpers, T-suppressors, NK cells, B-lymphocytes, phagocytic index, phagocytic number, IgG, IgA, IgM were determined before and after administration of OM-85. Statistical processing of the obtained results was performed by the method of variation statistics using computer programs Microsoft Office Excel. Results. The study revealed a significant increase in the incidence of ARI among young children in winter and spring and changes in immunological reactivity such as suppression of phagocytic link, imbalance in the ratio of T-lymphocyte populations, dysimmunoglobulinemia. In children of group II, mani­festations of general weakness disappeared 0.99 days ear­lier, cough — 1.45 days, catarrhal phenomena — 1.23 days earlier compared to the patients of group I (p < 0.05). After the protocol treatment, there was a positive dynamics in the content of the studied parameters in patients of group I, but their normalization did not occur. Besides, supplementation with OM-85 the­rapy contri­buted to the normalization of the phagocytic level, the concentration of CD3+, CD4+ and CD21+ lymphocytes, the restoration of IgA and IgM levels. Conclusions. The use of OM-85 in the treatment of respiratory infections contributes to reducing the period of acute intoxication, reducing the likelihood of bacterial complications. Clinical feasibility of bacterial lysates is associated with stimulation of systemic mechanisms of adaptive and innate immunity.


children; acute respiratory infection


Pechinka AM, Dzeman MI. Acute respiratory diseases: questions of clinical diagnostic and treatment (lecture). Ukrainian Medical Journal. 2010; 5 (79):95-103.

Smyan OI, Binda TP, Dmitrov EV, Sukhareva VA. Modern etiopathogenetic and clinical diagnostic features of acute respiratory viral infections in children. Journal of Clinical and Experimental Medical Research. 2013; 1(3): 321-328.

European Centre for Disease Prevention and Control. Antimicrobial resistance. Accessed November 1, 2016.

Shen K, Yang Y, Wang T [et al]. Diagnosis, treatment, and prevention of 2019 novel coronavirus infection in children: experts’ consensus statement. World J Pediatr. 2020;

Schaad UB, Esposito S, Razi CH. Diagnosis and management of recurrent respiratory tract infections in children: a practical guide. Arch Pediatr Infect Dis. 2016;4:e31039.


Grief SN. Upper respiratory infections. Prim Care. 2013;40:757‐770. doi: 10.1016/j.pop.2013.06.004.

Toivonen L, Karppinen S, Schuez-Havupalo L [et al]. Burden of Recurrent Respiratory Tract Infections in Children: A Prospective Cohort Study. Pediatr Infect Dis J. 2016 Dec;35(12):e362-e369. doi: 10.1097/INF.0000000000001304.

Yin J, Xu B, Zeng X, Shen K. Broncho‐Vaxom in pediatric recurrent respiratory tract infections: A systematic review and meta‐analysis. Int Immunopharmacol. 2018;54:198‐209. doi:


Koatz AM, Coe NA, Ciceran A, Alter AJ. Clinical and immunological benefits of OM‐85 bacterial lysate in patients with allergic rhinitis, asthma, and COPD and recurrent respiratory infections. Lung. 2016;194:687‐697. doi: 10.1007/s00408-016-9880-5.

Dang AT, Pasquali C, Ludigs K, Guarda G. OM‐85 is an immunomodulator of interferon‐beta production and inflammasome activity. Sci Rep. 2017;7:43844. doi: 10.1038/srep43844.

Kearney SC, Dziekiewicz M, Feleszko W. Immunoregulatory and immunostimulatory responses of bacterial lysates in respiratory infections and asthma. Ann Allergy Asthma Immunol. 2015;114:364‐369. doi: 10.1016/j.anai.2015.02.008.

Hryniewicz W. Rekomendacje postepowania w pozaszpitalnych zakazeniach ukladu oddechowego. 2016. http://www.antybiotyki. Accessed October 8, 2018.

American Academy of Otolaryngology‐Head and Neck Surgery. Tonsillitis. Accessed October 8, 2018.

Тapiainen T, Aittoniemi J, Immonen J [et al]. Finnish guidelines for the treatment of laryngitis, wheezing bronchitis and bronchiolitis in children. Acta Paediatr. 2016;105:44‐49. doi: 10.1111/apa.13162.

Rossi GA, Bessler W, Ballarini S[et al]. Evidence that a primary antiviral stimulation of the immune response by OM-85 reduces susceptibility to a secondary respiratory bacterial infection in mice. Ital J Pediatr. 2018;44, 112

Al'bickij VYu, Baranov AA. Chasto bolejushhie deti. Kliniko-social'nye aspekty, puti ozdorovlenija. Saratov: Medicina, 1986. 345p.[in Russian].

Esposito S, Soto-Martinez ME, Feleszko W, Jones MH, Shen KL, Schaad UB. Nonspecific immunomodulators for recurrent respiratory tract infections, wheezing and asthma in children: a systematic review of mechanistic and clinical evidence. Curr Opin Allergy Clin Immunol. 2018;18(3):198–209. doi:10.1097/ACI.0000000000000433/

Chen J, Zhou Y, Nie J [et al]. Bacterial lysate for the prevention of chronic rhinosinusitis recurrence in children. J Laryngol Otol 2017; 131:523–528. doi: 10.1017/S0022215117000524.

Bitar MA, Saade R. The role of OM-85 BV (Broncho-Vaxom) in preventing recurrent acute tonsillitis in children. Sovremennaya pediatriya.2015.6(70):25-29. doi: 10.1016/j.ijporl.2013.01.009.

Dang AT, Pasquali C, Ludigs K, Guarda G. OM-85 is an immunomodulator of interferon-β production and inflammasome activity. Sci Rep 2017; 7:43844. doi: 10.1038/srep43844.

Luan H, Zhang Q, Wang L [et al]. OM-85-BV induced the productions of IL-1 beta, IL-6, and TNF-alpha via TLR4-and TLR2-mediated ERK1/2/NF-kappa B pathway in RAW264.7 cells. J Interfer Cytok Res 2014; 34:526–536. doi: 10.1089/jir.2013.0077.

Kalyuzhin OV. OM-85 in the prevention / treatment of respiratory infections and exacerbations of chronic lung diseases: selection criteria, mechanisms and evidence. Lechashchyi vrach. Lechashchyi vrach. 2018;(3):77-82.

Del-Rio-Navarro BE, Espinosa-Rosales FJ, Flenady V, Sienra-Mongen JJL. Cochrane Review: Immunostimulants for preventing respiratory tract infection in children. Evidence Based Child Health. 2012;(7):629–717. doi:10.1002/ebch.1833.

Schaad UB. OM-85 BV, an immunostimulant in pediatric recurrent respiratory tract infections:a systematic review. World J Pediatr.2010;6(1):5-12. doi: 10.1007/s12519-010-0001-x.

De Benedetto F, Sevieri G. Prevention of respiratory tract infections with bacterial lysate OM-85 bronchomunal in children and adults: a state of the art. Multidisciplin Respir Med. 2013;8(1):33. doi: 10.1186/2049-6958-8-33.

Razi CH, Harmancı K, Abacı A, Özdemir O [et al]. Kattacks in preschool children. J Allergy ClinImmunol. 2010;126(4):763-769. doi: 10.1016/j.jaci.2010.07.

Manolova V, Flace A, Jeandet P, Bessler WC, Pasquali C. Biomarkers induced by the mmunomodulatory bacterial extract OM-85: 10.4172/2155-9899.1000494.

Zaplatnikov AL, Leonidovich A, Girina AA [et al]. Polyvalent mechanical bacterial lysate in children with recurrent infections of the respiratory system: using experience, efficacy and safety. Pediatriya Zhurnal im GN Speranskogo 2016; 95:96–101.

Lu Y, Li Y, Xu L [et al]. Bacterial lysate increases the percentage of natural killer T cells in peripheral blood and alleviates asthma in children. Pharmacology 2015; 95:139–144. doi: 10.1159/000377683.

Bartkowiak-Emeryk M. The influence of polyvalent mechanical bacterial lysate on immunological parameters in asthmatic children. European Academy of Allergy and Clinical Immunology Congress 17–21 June 2017 Helsinki (Abstract 0078).

Simon AK, Hollander GA, McMichael A. Evolution of the immune system in humans

from infancy to old age. Proc Biol Sci. 2015;(282):20143085. doi: 10.1098/rspb.2014.3085.

Dronov IA, Denisova AR. Bacterial lysate OM-85: efficacy issues in children and the potential role in inhibiting the growth of antimicrobial resistance. Voprosы praktycheskoi pedyatryy. 2019;14(1):76–83. doi: 10.20953/1817-7646-2019-1-76-83.

Rodrigues A, Gualdi LP, de Souza RG [et al]. Bacterial extract (OM-85) with human-equivalent doses does not inhibit the development of asthma in a murine model. Allergol Immunopathol 2016; 44:504–511. doi: 10.1016/j.aller.2016.04.010.

Copyright (c) 2020 ACTUAL INFECTOLOGY

Creative Commons License
This work is licensed under a Creative Commons Attribution 4.0 International License.


© Publishing House Zaslavsky, 1997-2020


   Seo анализ сайта