Preliminary pediatric clinical evaluation of the oral probiotic Streptococcus salivarius K12 in preventing recurrent pharyngitis and/or tonsillitis caused by Streptococcus pyogenes and recurrent acute otitis media

Francesco Di Pierro, Guido Donato, Federico Fomia, Teresa Adami, Domenico Careddu, Claudia Cassandro, Roberto Albera, Francesco Di Pierro, Guido Donato, Federico Fomia, Teresa Adami, Domenico Careddu, Claudia Cassandro, Roberto Albera

Abstract

Background: The oral probiotic Streptococcus salivarius K12 has been shown clearly to antagonize the growth of Streptococcus pyogenes, the most important bacterial cause of pharyngeal infections in humans, by releasing two bacteriocins named salivaricin A2 and salivaricin B. Unpublished observations indicate that it can also antagonize the growth of other bacteria involved in acute otitis media. Because of its ability to colonize the oral cavity and its safety profile, we have tested its efficacy in reducing the incidence of streptococcal pharyngitis and/or tonsillitis and episodes of acute otitis media.

Methods: We enrolled 82 children, including 65 with and 17 without a recent diagnosis of recurrent oral streptococcal pathology. Of those with recurrent pathology, 45 were treated daily for 90 days with an oral slow-release tablet containing five billion colony-forming units of S. salivarius K12 (Bactoblis(®)), and the remaining 20 served as an untreated control group. The 17 children without a recent diagnosis of recurrent oral pathology were used as an additional control group. After 90 days of treatment, a 6-month follow-up period without treatment was included to evaluate a possible persistent protective role for the previously administered product.

Results: The 41 children who completed the 90-day course of Bactoblis showed a reduction in their episodes of streptococcal pharyngeal infection (about 90%) and/or acute otitis media (about 40%), calculated by comparing infection rates in the previous year. The 90-day treatment also reduced the reported incidence of pharyngeal and ear infections by about 65% in the 6-month follow-up period during which the product was not administered. Subjects tolerated the product well, with no side effects or dropouts reported.

Conclusion: Prophylactic administration of S. salivarius K12 to children with a history of recurrent oral streptococcal pathology reduced episodes of streptococcal pharyngeal infections and/or tonsillitis as well as episodes of acute otitis media.

Keywords: BLIS K12; Bactoblis®; Streptococcus salivarius K12; acute otitis media; bacteriocin-like inhibitory substance K12; pharyngitis; tonsillitis.

References

    1. Sathyabama S, Vijayabharathi R, Bruntha Devi P, Ranjith Kumar M, Priyadarisini VB. Screening for probiotic properties of strains isolated from feces of various human groups. J Microbiol. 2012;50:603–612.
    1. Tagg JR, Dierksen KP. Bacterial replacement therapy: adapting ‘germ warfare’ to infection prevention. Trends Biotechnol. 2003;21:217–223.
    1. Tagg JR. Prevention of streptococcal pharyngitis by anti-Streptococcus pyogenes bacteriocin-like inhibitory substances (BLIS) produced by Streptococcus salivarius. Indian J Med Res. 2004;119(Suppl):13–16.
    1. Jack RW, Tagg JR, Ray B. Bacteriocins of Gram-positive bacteria. Microbiol Rev. 1995;59:171–200.
    1. Hyink O, Wescombe PA, Upton M, Ragland N, Burton JP, Tagg JR. Salivaricin A2 and the novel lantibiotic salivaricin B are encoded at adjacent loci on a 190-kilobase transmissible megaplasmid in the oral probiotic strain Streptococcus salivarius K12. Appl Environ Microbiol. 2007;73:1107–1113.
    1. Sharma S, Verma KK. Skin and soft tissue infection. Indian J Pediatr. 2001;68(Suppl 3):S46–S50.
    1. Wescombe PA, Burton JP, Cadieux PA, et al. Megaplasmids encode differing combinations of lantibiotics in Streptococcus salivarius. Antonie Van Leeuwenhoek. 2006;90:269–280.
    1. Burton JP, Chilcott CN, Tagg JR. The rationale and potential for the reduction of oral malodour using Streptococcus salivarius probiotics. Oral Dis. 2005;11(Suppl 1):29–31.
    1. van Zon A, van der Heijden GJ, van Dongen TM, Burton MJ, Schilder AG. Antibiotics for otitis media with effusion in children. Cochrane Database Syst Rev. 2012;9:CD009163.
    1. Burton JP, Chilcott CN, Moore CJ, Speiser G, Tagg JR. A preliminary study of the effect of probiotic Streptococcus salivarius K12 on oral malodour parameters. J Appl Microbiol. 2006;100:754–764.
    1. Power DA, Burton JP, Chilcott CN, Dawes PJ, Tagg JR. Preliminary investigations of the colonisation of upper respiratory tract tissues of infants using a paediatric formulation of the oral probiotic Streptococcus salivarius K12. Eur J Clin Microbiol Infect Dis. 2008;27:1261–1263.
    1. Horz HP, Meinelt A, Houben B, Conrads G. Distribution and persistence of probiotic Streptococcus salivarius K12 in the human oral cavity as determined by real-time quantitative polymerase chain reaction. Oral Microbiol Immunol. 2007;22:126–130.
    1. Burton JP, Wescombe PA, Moore CJ, Chilcott CN, Tagg JR. Safety assessment of the oral cavity probiotic Streptococcus salivarius K12. Appl Environ Microbiol. 2006;72:3050–3053.
    1. Burton JP, Cowley S, Simon RR, McKinney J, Wescombe PA, Tagg JR. Evaluation of safety and human tolerance of the oral probiotic Streptococcus salivarius K12: a randomized, placebo-controlled, double-blind study. Food Chem Toxicol. 2011;49:2356–2364.
    1. Tagg J, Wescombe P, Burton J. Oral streptococcal BLIS: heterogeneity of the effector molecules and potential role in the prevention of streptococcal infections. International Congress Series 1289. 2006:347–350.
    1. Vandenbroucke JP. A shortcut method for calculating the 95 per cent confidence interval of the standardised mortality ratio. Am J Epidemiol. 1982;115:303–304.
    1. Tagg JR. A longitudinal study of Lancefield group A streptococcus acquisitions by a group of young Dunedin school children. N Z Med J. 1990;103:429–431.
    1. Fantinato VC, Shimizu MT. Production of bacteriocin-like inhibitory substances (BLIS) by Streptococcus salivarius strains isolated from the tongue and throat of children with and without sore throat. Revista de Microbiologia. 1999;30:332–334.
    1. Ragland N, Tagg JR. Applications of bacteriocin-like inhibitory substance (BLIS) typing in a longitudinal study of the oral carriage of beta-haemolytic streptococci by a group of Dunedin schoolchildren. Zentralbl Bakteriol. 1990;274:100–108.
    1. Tagg JR. Significance of bacteriocin production by oral streptococci. In: Lutticken R, editor. Proceedings of the Xth Lancefield Symposium. New York, NY: Gustav Fischer Verlag; 1990.
    1. Dierksen KP, Tagg JR. The influence of indigenous bacteriocin-producing Streptococcus salivarius on the acquisition of Streptococcus pyogenes by primary school children in Dunedin, New Zealand. In: Martin DR, Tagg JR, editors. Streptococci and Streptococcal Diseases Entering the New Millenium. Auckland, New Zealand: Securacopy; 2000.
    1. Roos K, Hakansson EG, Holm S. Effect of recolonisation with “interfering” alpha streptococci on recurrences of acute and secretory otitis media in children: randomized placebo controlled trial. BMJ. 2001;322:210–212.
    1. Tano K, Olofsson C, Grahn-Hakansson E, Holm SE. In vitro inhibition of S. pneumoniae, nontypable H. influenzae and M. catharralis by alpha-hemolytic streptococci from healthy children. Int J Pediatr Otorhinolaryngol. 1999;47:49–56.

Source: PubMed

Patrocinadores e Colaboradores

Condições médicas

Intervenções de drogas

3
Se inscrever