Research Article

Efficacy of OM-85 in Children with Recurrent Respiratory Tract Infections: Relationship with Allergic and Immunological Features

Volume: 52 October 6, 2026
EN TR

Efficacy of OM-85 in Children with Recurrent Respiratory Tract Infections: Relationship with Allergic and Immunological Features

Abstract

OM-85 is an immunomodulatory agent used for the prevention of recurrent respiratory tract infections (RTIs) in children; however, the influence of allergic and immunological characteristics on treatment response remains unclear. This study evaluated changes in infection frequency before and after OM-85 treatment and examined whether treatment response was associated with allergic status or immunological characteristics. This single-center, retrospective cohort study included 114 children treated with OM-85 for recurrent RTIs. Annual upper (URTI) and lower (LRTI) respiratory tract infection episodes before and after treatment were compared. Treatment responses were analyzed according to atopic status, inhalant allergen sensitization, and immunoglobulin status (normal, transient hypogammaglobulinemia, and partial IgA deficiency). Independent predictors of post-treatment infection burden were assessed using multivariable linear (ANCOVA) and negative binomial regression analyses. The median age was 56.5 months; 46.5% of patients were atopic, 28.1% had partial IgA deficiency, and 8.8% had transient hypogammaglobulinemia. Following OM-85 treatment, median annual URTI episodes decreased from 8 to 5 (40.6%; p<0.001; r=0.78), and LRTI episodes from 1 to 0 (63.2%; p<0.001; r=0.54). The proportion of children with frequent URTIs (≥6/year) declined from 84.2% to 33.3%, and those with at least one LRTI episode from 60.5% to 32.5%. The reduction was significant in both atopic and non-atopic patients and in subgroups with normal or low immunoglobulin levels. In multivariable analysis, the only independent predictor of post-treatment burden was baseline infection burden. OM-85 treatment was associated with a reduction in both upper and lower respiratory tract infection frequency independently of allergic status and serum immunoglobulin level, with baseline infection burden being the factor most strongly associated with post-treatment infection burden. The greatest clinical benefit is expected in children with frequent infections, and this group may constitute a priority target population for this preventive strategy.

Keywords

Supporting Institution

The authors declared that they received no financial support for this study.

Ethical Statement

Ethics Committee Approval Information: Approving Committee: University of Health Sciences, Bursa Faculty of Medicine, and the Bursa City Hospital Approval Date: 05.02.2025 Decision No: 2025-3/1

References

  1. 1. 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(1):e31039.
  2. 2. 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;35(12):e362-e369. doi:10.1097/INF.0000000000001304
  3. 3. Soto-Martinez ME, Feleszko W, Moeller A. Bacterial-Derived Immunomodulators as a Preventive Strategy for Viral Respiratory Tract Infections and Associated Wheezing or Asthma in Children: A Targeted Narrative Review. Children (Basel). 2026;13(6):737. Published 2026 May 26. doi:10.3390/children13060737
  4. 4. de Martino M, Ballotti S. The child with recurrent respiratory infections: normal or not?. Pediatr Allergy Immunol. 2007;18 Suppl 18:13-18. doi:10.1111/j.1399-3038.2007.00625.x
  5. 5. Cardinale F, Fiore M, Piacentini G, Varricchio A. OM-85 in the prevention of recurrent respiratory infections in children: State of the art. J Biol Regul Homeost Agents. 2023;37(11). doi:10.23812/j.biol.regul.homeost.agents.20233711.551
  6. 6. Cuppari C, Colavita L, Miraglia Del Giudice M, Chimenz R, Salpietro C. Recurrent respiratory infections between immunity and atopy. Pediatr Allergy Immunol. 2020;31 Suppl 24:19-21. doi:10.1111/pai.13160
  7. 7. Rossi GA, Pohunek P, Feleszko W, Ballarini S, Colin AA. Viral infections and wheezing-asthma inception in childhood: is there a role for immunomodulation by oral bacterial lysates?. Clin Transl Allergy. 2020;10:17. Published 2020 Jun 3. doi:10.1186/s13601-020-00322-1
  8. 8. Stiehm ER. The four most common pediatric immunodeficiencies. J Immunotoxicol. 2008;5(2):227-234. doi:10.1080/15476910802129646

Details

Primary Language

English

Subjects

Allergy

Journal Section

Research Article

Publication Date

October 6, 2026

Submission Date

July 29, 2026

Acceptance Date

September 16, 2026

Published in Issue

Year 2026 Volume: 52

APA
Karalı, Y., Karalı, Z., & Terzi, H. Z. (2026). Efficacy of OM-85 in Children with Recurrent Respiratory Tract Infections: Relationship with Allergic and Immunological Features. Journal of Uludağ University Medical Faculty, 52. https://doi.org/10.32708/uutfd.2004716
AMA
1.Karalı Y, Karalı Z, Terzi HZ. Efficacy of OM-85 in Children with Recurrent Respiratory Tract Infections: Relationship with Allergic and Immunological Features. Journal of Uludağ University Medical Faculty. 2026;52. doi:10.32708/uutfd.2004716
Chicago
Karalı, Yasin, Zuhal Karalı, and Hatice Zeynep Terzi. 2026. “Efficacy of OM-85 in Children With Recurrent Respiratory Tract Infections: Relationship With Allergic and Immunological Features”. Journal of Uludağ University Medical Faculty 52 (October). https://doi.org/10.32708/uutfd.2004716.
EndNote
Karalı Y, Karalı Z, Terzi HZ (October 1, 2026) Efficacy of OM-85 in Children with Recurrent Respiratory Tract Infections: Relationship with Allergic and Immunological Features. Journal of Uludağ University Medical Faculty 52
IEEE
[1]Y. Karalı, Z. Karalı, and H. Z. Terzi, “Efficacy of OM-85 in Children with Recurrent Respiratory Tract Infections: Relationship with Allergic and Immunological Features”, Journal of Uludağ University Medical Faculty, vol. 52, Oct. 2026, doi: 10.32708/uutfd.2004716.
ISNAD
Karalı, Yasin - Karalı, Zuhal - Terzi, Hatice Zeynep. “Efficacy of OM-85 in Children With Recurrent Respiratory Tract Infections: Relationship With Allergic and Immunological Features”. Journal of Uludağ University Medical Faculty 52 (October 1, 2026). https://doi.org/10.32708/uutfd.2004716.
JAMA
1.Karalı Y, Karalı Z, Terzi HZ. Efficacy of OM-85 in Children with Recurrent Respiratory Tract Infections: Relationship with Allergic and Immunological Features. Journal of Uludağ University Medical Faculty. 2026;52. doi:10.32708/uutfd.2004716.
MLA
Karalı, Yasin, et al. “Efficacy of OM-85 in Children With Recurrent Respiratory Tract Infections: Relationship With Allergic and Immunological Features”. Journal of Uludağ University Medical Faculty, vol. 52, Oct. 2026, doi:10.32708/uutfd.2004716.
Vancouver
1.Yasin Karalı, Zuhal Karalı, Hatice Zeynep Terzi. Efficacy of OM-85 in Children with Recurrent Respiratory Tract Infections: Relationship with Allergic and Immunological Features. Journal of Uludağ University Medical Faculty. 2026 Oct. 1;52. doi:10.32708/uutfd.2004716

ISSN: 1300-414X, e-ISSN: 2645-9027

Creative Commons License
Journal of Uludag University Medical Faculty is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.
2023