Back to Browse Journals » International Journal of General Medicine » Volume 5

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

Authors Di Pierro F, Donato G, Fomia F, Adami T, Careddu D, Cassandro C, Albera R

Received 8 October 2012

Accepted for publication 25 October 2012

Published 30 November 2012 Volume 2012:5 Pages 991—997


Checked for plagiarism Yes

Review by Single-blind

Peer reviewer comments 3

Francesco Di Pierro,1 Guido Donato,2 Federico Fomia,3 Teresa Adami,4 Domenico Careddu,5 Claudia Cassandro,6 Roberto Albera6

1Scientific Department, Velleja Research, Milano, 2ASL 1, Cuneo, 3ASL 3, Brescia, 4Infective Diseases, Verona, 5ASL 13, Novara, 6Surgical Science Department, Università degli Studi, Torino, Italy

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cause of pharyngeal infections in humans, by releasing two bacteriocins named salivaricin A2 and salivaricin B. Unpublished observations indicate that it can also antagonize the growth of other bacteria involved in acute otitis media.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, bacteriocin-like inhibitory substance K12, Streptococcus salivarius K12, Bactoblis®, pharyngitis, tonsillitis, acute otitis media

Creative Commons License This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at and incorporate the Creative Commons Attribution - Non Commercial (unported, v3.0) License. By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms.

Download Article [PDF] View Full Text [HTML] 


Other articles by this author:

Use of Streptococcus salivarius K12 in the prevention of streptococcal and viral pharyngotonsillitis in children

Di Pierro F, Colombo M, Zanvit A, Risso P, Rottoli AS

Drug, Healthcare and Patient Safety 2014, 6:15-20

Published Date: 13 February 2014

Post-steroid management of chronic vulvar itching with a topical formula containing natural anti-itching and anti-inflammatory actives

Di Pierro F, Di Maio E, Di Paola G, Felice R, Murina F

International Journal of Women's Health 2013, 5:187-191

Published Date: 19 April 2013

Pilot study on the additive effects of berberine and oral type 2 diabetes agents for patients with suboptimal glycemic control

Di Pierro F, Villanova N, Agostini F, Marzocchi R, Soverini V, Marchesini G

Diabetes, Metabolic Syndrome and Obesity: Targets and Therapy 2012, 5:213-217

Published Date: 17 July 2012

Readers of this article also read:

Green synthesis of water-soluble nontoxic polymeric nanocomposites containing silver nanoparticles

Prozorova GF, Pozdnyakov AS, Kuznetsova NP, Korzhova SA, Emel’yanov AI, Ermakova TG, Fadeeva TV, Sosedova LM

International Journal of Nanomedicine 2014, 9:1883-1889

Published Date: 16 April 2014

Single- and multiple-dose pharmacokinetics, pharmacodynamics, and safety of apixaban in healthy Chinese subjects [Corrigendum]

Cui Y, Song Y, Wang J, Yu Z, Schuster A, Barrett YC, Frost C

Clinical Pharmacology: Advances and Applications 2014, 6:61-62

Published Date: 27 March 2014

Pharmacokinetics and pharmacodynamics of acetylsalicylic acid after intravenous and oral administration to healthy volunteers

Nagelschmitz J, Blunck M, Kraetzschmar J, Ludwig M, Wensing G, Hohlfeld T

Clinical Pharmacology: Advances and Applications 2014, 6:51-59

Published Date: 19 March 2014

Methacrylic-based nanogels for the pH-sensitive delivery of 5-Fluorouracil in the colon

Ashwanikumar N, Kumar NA, Nair SA, Kumar GS

International Journal of Nanomedicine 2012, 7:5769-5779

Published Date: 15 November 2012

A novel preparation method for silicone oil nanoemulsions and its application for coating hair with silicone

Hu Z, Liao M, Chen Y, Cai Y, Meng L, Liu Y, Lv N, Liu Z, Yuan W

International Journal of Nanomedicine 2012, 7:5719-5724

Published Date: 12 November 2012

Cross-linked acrylic hydrogel for the controlled delivery of hydrophobic drugs in cancer therapy

Deepa G, Thulasidasan AK, Anto RJ, Pillai JJ, Kumar GS

International Journal of Nanomedicine 2012, 7:4077-4088

Published Date: 27 July 2012

Detemir as a once-daily basal insulin in type 2 diabetes

Nelson SE

Clinical Pharmacology: Advances and Applications 2011, 3:27-37

Published Date: 18 August 2011

Particle size reduction to the nanometer range: a promising approach to improve buccal absorption of poorly water-soluble drugs

Rao S, Song Y, Peddie F, Evans AM

International Journal of Nanomedicine 2011, 6:1245-1251

Published Date: 20 June 2011

Crystallization after intravitreal ganciclovir injection

Pitipol Choopong, Nattaporn Tesavibul, Nattawut Rodanant

Clinical Ophthalmology 2010, 4:709-711

Published Date: 14 July 2010