Streptococcus salivarius 24SMB administered by nasal spray for the prevention of acute otitis media in otitis-prone children

Abstract

This paper reports the results of the first study in which Streptococcus salivarius 24SMB, a safe α-haemolytic strain capable of producing bacteriocin-like substances with significant activity against acute otitis media (AOM) pathogens, was intranasally administered in an attempt to reduce the risk of new episodes of AOM in otitis-prone children. In this prospective, randomized, double-blind, placebo-controlled study, 100 children aged 1–5 years with histories of recurrent AOM were randomized 1:1 to receive an intranasal S. salivarius 24SMB or placebo twice daily for 5 days each month for 3 consecutive months. Fifty treated children and 47 who received placebo who were compliant with study protocol were followed monthly for 6 months. The number of children who did not experience any AOM was higher among the children treated with the S. salivarius 24SMB preparation than among those in the placebo group (30.0 vs 14.9 %; p = 0.076). Moreover, the number of children who received antibiotics during the study period was lower among the children treated with S. salivarius 24 SMB than among those who received placebo (70 vs 83.0 %; p = 0.13). Compared with the children who were not colonized by S. salivarius 24SMB after treatment, the number of colonized children who experienced any AOM was significantly lower (42.8 vs 13.6 %; p = 0.03). Similar results were observed when the children treated with antibiotics for AOM were analysed (67.8 vs 95.5 %; p = 0.029). This study revealed the ability of intranasally administered S. salivarius 24SMB to reduce the risk of AOM in otitis-prone children.

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References

  1. 1.

    Grevers G (2010) First International Roundtable ENT Meeting Group. Challenges in reducing the burden of otitis media disease: an ENT perspective on improving management and prospects for prevention. Int J Pediatr Otorhinolaryngol 74:572–577

    Article  PubMed  Google Scholar 

  2. 2.

    Marchisio P, Nazzari E, Torretta S, Esposito S, Principi N (2014) Medical prevention of recurrent acute otitis media: an updated overview. Expert Rev Anticancer Ther 12:611–620

    CAS  Article  Google Scholar 

  3. 3.

    Morris PS, Leach AJ (2008) Antibiotics for persistent nasal discharge (rhinosinusitis) in children. Cochrane Database Syst Rev 2:CD001094

    PubMed  Google Scholar 

  4. 4.

    Lim A, Cranswick N, South M (2011) Adverse events associated with the use of complementary and alternative medicine in children. Arch Dis Child 96:297–300

    Article  PubMed  Google Scholar 

  5. 5.

    Tano K, Olofsson C, Grahn-Hakansson E, Holm SE (1999) In vitro inhibition of S. pneumoniae, nontypeable H. influenzae and M. catharralis by alpha-hemolytic streptococci from healthy children. Int J Pediatr Otorhinolaryngol 47:49–56

    CAS  Article  PubMed  Google Scholar 

  6. 6.

    Brook I, Gober AE (2000) In vitro bacterial interference in the nasopharynx of otitis mediaprone and non-otitis media-prone children. Arch Otolaryngol Head Neck Surg 126:1011–1013

    CAS  Article  PubMed  Google Scholar 

  7. 7.

    Bernstein JM, Faden HF, Dryja DM, Wactawski-Wende J (1993) Micro-ecology of the nasopharyngeal bacterial flora in otitis-prone and non-otitis-prone children. Acta Otolaryngol 113:88–92

    CAS  Article  PubMed  Google Scholar 

  8. 8.

    Marchisio P, Claut L, Rognoni A, Esposito S, Passali D, Bellussi L, Drago L, Pozzi G, Mannelli S, Schito G, Principi N (2003) Differences in nasopharyngeal bacterial flora in children with nonsevere recurrent acute otitis media and chronic otitis media with effusion: implications for management. Pediatr Infect Dis J 22:262–268

    PubMed  Google Scholar 

  9. 9.

    Roos K, Håkansson EG, Holm S (2001) Effect of recolonisation with “interfering” alpha streptococci on recurrences of acute and secretory otitis media in children: randomised placebo controlled trial. BMJ 322:210–212

    PubMed Central  CAS  Article  PubMed  Google Scholar 

  10. 10.

    Doern CD, Burnham CA (2010) It’s not easy being green: the viridans group streptococci, with a focus on pediatric clinical manifestations. J Clin Microbiol 48:3829–3835

    PubMed Central  Article  PubMed  Google Scholar 

  11. 11.

    Santagati M, Scillato M, Patanè F, Aiello C, Stefani S (2012) Bacteriocin-producing oral streptococci and inhibition of respiratory pathogens. FEMS Immunol Med Microbiol 65:23–31

    CAS  Article  PubMed  Google Scholar 

  12. 12.

    Santagati M, Scillato M, Muscaridola N, Metoldo V, La Mantia I, Stefani S (2015) Colonization, safety, and tolerability study of the S. salivarius 24SMBc nasal spray for its application in upper respiratory tract infections. Eur J Clin Microbiol Infect Dis 34(10):2075–2080

  13. 13.

    Ilia S, Goulielmos GN, Samonis G, Galanakis E (2014) Polymorphisms in IL-6, IL-10, TNF-α, IFN-γ and TGF-β1 genes and susceptibility to acute otitis media in early infancy. Pediatr Infect Dis J 33:518–521

    Article  PubMed  Google Scholar 

Download references

Acknowledgments

This study was supported by a grant obtained from DMG Italia S.r.l.

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The author(s) declare that they have no competing interests.

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Correspondence to S. Esposito.

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Marchisio, P., Santagati, M., Scillato, M. et al. Streptococcus salivarius 24SMB administered by nasal spray for the prevention of acute otitis media in otitis-prone children. Eur J Clin Microbiol Infect Dis 34, 2377–2383 (2015). https://doi.org/10.1007/s10096-015-2491-x

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Keywords

  • Acute Otitis Medium
  • Nasopharyngeal Swab
  • Control Visit
  • Local Adverse Event
  • Recurrent Acute Otitis Medium