Anna Cantarutti1, Federico Rea2, Daniele Donà3, Luigi Cantarutti4, Andrea Passarella5, Antonio Scamarcia6, Rebecca Lundin7, Valerio Damiani8, Carlo Giaquinto9, Giovanni Corrao10. 1. Laboratory of Healthcare Research & Pharmacoepidemiology, Unit of Biostatistics, Epidemiology and Public Health, Department of Statistics and Quantitative Methods, University of Milano-Bicocca, Milan, Italy. Electronic address: anna.cantarutti@unimib.it. 2. Laboratory of Healthcare Research & Pharmacoepidemiology, Unit of Biostatistics, Epidemiology and Public Health, Department of Statistics and Quantitative Methods, University of Milano-Bicocca, Milan, Italy. Electronic address: f.rea@campus.unimib.it. 3. Department for Woman and Child Health, University of Padua, Padua, Italy. Electronic address: daniele.dona@phd.unipd.it. 4. Pedianet Project, Padua, Italy. Electronic address: l.cantarutti@sosepe.com. 5. Pedianet Project, Padua, Italy. Electronic address: apassarella61@gmail.com. 6. Pedianet Project, Padua, Italy. Electronic address: a.scamarcia@sosepe.com. 7. PENTA Foundation, Padua, Italy. Electronic address: Lundin.rebecca@gmail.com. 8. DMG Medical Department, Pomezia, Italy. Electronic address: valerio.damiani@dmgit.com. 9. Department for Woman and Child Health, University of Padua, Padua, Italy. Electronic address: carlo.giaquinto@unipd.it. 10. Laboratory of Healthcare Research & Pharmacoepidemiology, Unit of Biostatistics, Epidemiology and Public Health, Department of Statistics and Quantitative Methods, University of Milano-Bicocca, Milan, Italy. Electronic address: giovanni.corrao@unimib.it.
Abstract
INTRODUCTION: Acute otitis media (AOM) is the most common childhood disease leading to antibiotic use. More than 80% of children under three years of age experience at least one episode, and about one-third of these report significant recurrence of episodes. In recent years, several studies reported that normal nasopharyngeal flora inhibits growth of common otopathogens, suggesting that maintenance of an "adequate" nasopharyngeal flora might prevent occurrence of upper respiratory tract infections, including AOM. This study aims to determine whether five-month treatment with Streptococcus salivarius 24SMB and Streptococcus oralis 89a nasal spray prevents recurrence of AOM and prescription of antibiotics in children with diagnosis of recurrent AOM. METHODS: Observational prospective cohort study including children aged 1-6 years with diagnosis of recurrent AOM registered with 31 Italian family pediatricians. 81 children were enrolled in the study from September 2016 to the end of the five therapeutic cycles of the Streptococcus salivarius 24SMB and Streptococcus oralis 89a supplied 7 days each month for 5 consecutive months. For each treated child, one untreated control was randomly selected, 1:1 matched for gender, age, and follow-up. RESULTS: 158 children (79 treated and 70 untreated) were included into the analysis (mean age, 3.9 years; 47% female). Univariate analysis showed a statistically significant 34% (95% CI 1%-56%) reduction in number of AOM episodes in treated children compared with those not treated. Significantly fewer antibiotics were dispensed among treated children (24%, 95% CI 1%-41%). CONCLUSIONS: Our findings suggest that intermittent treatment of children with diagnosis of recurrent AOM with nasal spray containing Streptococcus salivarius 24SMB and Streptococcus oralis 89a for a period of five months might be effective in preventing antibiotic use associated with recurrent episodes of AOM. Additional larger studies to address this important clinical problem are recommended.
INTRODUCTION: Acute otitis media (AOM) is the most common childhood disease leading to antibiotic use. More than 80% of children under three years of age experience at least one episode, and about one-third of these report significant recurrence of episodes. In recent years, several studies reported that normal nasopharyngeal flora inhibits growth of common otopathogens, suggesting that maintenance of an "adequate" nasopharyngeal flora might prevent occurrence of upper respiratory tract infections, including AOM. This study aims to determine whether five-month treatment with Streptococcus salivarius 24SMB and Streptococcus oralis 89a nasal spray prevents recurrence of AOM and prescription of antibiotics in children with diagnosis of recurrent AOM. METHODS: Observational prospective cohort study including children aged 1-6 years with diagnosis of recurrent AOM registered with 31 Italian family pediatricians. 81 children were enrolled in the study from September 2016 to the end of the five therapeutic cycles of the Streptococcus salivarius 24SMB and Streptococcus oralis 89a supplied 7 days each month for 5 consecutive months. For each treated child, one untreated control was randomly selected, 1:1 matched for gender, age, and follow-up. RESULTS: 158 children (79 treated and 70 untreated) were included into the analysis (mean age, 3.9 years; 47% female). Univariate analysis showed a statistically significant 34% (95% CI 1%-56%) reduction in number of AOM episodes in treated children compared with those not treated. Significantly fewer antibiotics were dispensed among treated children (24%, 95% CI 1%-41%). CONCLUSIONS: Our findings suggest that intermittent treatment of children with diagnosis of recurrent AOM with nasal spray containing Streptococcus salivarius 24SMB and Streptococcus oralis 89a for a period of five months might be effective in preventing antibiotic use associated with recurrent episodes of AOM. Additional larger studies to address this important clinical problem are recommended.
Authors: Elisa Barbieri; Gloria Porcu; Tianyan Hu; Tanaz Petigara; Francesca Senese; Gian Marco Prandi; Antonio Scamarcia; Luigi Cantarutti; Anna Cantarutti; Carlo Giaquinto Journal: Children (Basel) Date: 2022-03-19