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Bacteriotherapy with Streptococcus salivarius 24SMB and Streptococcus oralis 89a nasal spray for treatment of upper respiratory tract infections in children: a pilot study on short-term efficacy

BACKGROUND: Recurrent respiratory infections (RRIs) are defined by the presence of at least one of the following criteria: (i) > 6 annual respiratory infections (RIs); (ii) > 1 monthly RIs involving the upper airways from September to April; (iii) > 3 annual RIs involving the lower airways...

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Autores principales: Manti, Sara, Parisi, Giuseppe Fabio, Papale, Maria, Licari, Amelia, Salpietro, Carmelo, Miraglia del Giudice, Michele, Marseglia, Gian Luigi, Leonardi, Salvatore
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7126168/
https://www.ncbi.nlm.nih.gov/pubmed/32245500
http://dx.doi.org/10.1186/s13052-020-0798-4
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author Manti, Sara
Parisi, Giuseppe Fabio
Papale, Maria
Licari, Amelia
Salpietro, Carmelo
Miraglia del Giudice, Michele
Marseglia, Gian Luigi
Leonardi, Salvatore
author_facet Manti, Sara
Parisi, Giuseppe Fabio
Papale, Maria
Licari, Amelia
Salpietro, Carmelo
Miraglia del Giudice, Michele
Marseglia, Gian Luigi
Leonardi, Salvatore
author_sort Manti, Sara
collection PubMed
description BACKGROUND: Recurrent respiratory infections (RRIs) are defined by the presence of at least one of the following criteria: (i) > 6 annual respiratory infections (RIs); (ii) > 1 monthly RIs involving the upper airways from September to April; (iii) > 3 annual RIs involving the lower airways represent a very common health problem in the first years of life. We conducted a multi-centre, prospective, single-open study to assess the efficacy and the safety of Streptococcus salivarius 24SMBc and Streptococcus oralis 89a in the prevention of upper respiratory tract infections (URTIs) in children. METHODS: Ninety-one children (M:F = 47:44, mean age 7.4 ± 2.3 years) with RRIs were enrolled in the study between September and November 2018. At baseline, children received Streptococcus salivarius 24SMBc and Streptococcus oralis 89a as 2 puffs for nostril twice/day for 7 days/months. The treatment lasted for 3 consecutive months. Efficacy was expressed in terms of absence or presence of fever, cough, bronchospasm, rhinorrhea and otalgia, at 1 month (T1), and 3 (T3) months. Safety and tolerability of the probiotic were evaluated on the basis of the number and type of adverse events (AEs) recorded during the treatment. RESULTS: Children treated with Streptococcus salivarius 24SMBc and Streptococcus oralis 89a showed a significant decrease of symptoms including episodes of fever, cough, bronchospasm, rhinorrhea, and otalgia (p < 0.001) compared to baseline. The treatment significantly reduced the number of episodes of fever, cough, bronchospasm, rhinorrhea, otalgia, and cough also in patients with positive familial history for atopy and in atopic children (p < 0.05). No significant differences in symptoms among children with negative familial history for atopy and children with positive familial history for atopy subgroups, not atopic and atopic children subgroups, and smoke-exposed and not smoke-exposed subgroups were observed (p > 0.05). Conducting a subgroup analysis according to the age, it has been reported that children aged 1–3 years old showed an improvement in all symptoms, however, they become statistically significant only at the end of the 3 months of treatment (p < 0.05). Conversely, in children aged 3–6 and 6–12 years old, the therapeutic efficacy was progressive and significant already from the first month of therapy (p < 0.05). None of the children were withdrawn from the study because of AEs, although 9 children experienced burning nose leading to interruption of therapy. CONCLUSIONS: Our findings suggest that Streptococcus salivarius 24SMBc and Streptococcus oralis 89a treatment is safe and seems to be effective on short-term in the treatment of RRIs. Studies involving a longer observation period are necessary to establish the real efficacy of the product for the treatment of pediatric patients affected by RRIs.
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spelling pubmed-71261682020-04-10 Bacteriotherapy with Streptococcus salivarius 24SMB and Streptococcus oralis 89a nasal spray for treatment of upper respiratory tract infections in children: a pilot study on short-term efficacy Manti, Sara Parisi, Giuseppe Fabio Papale, Maria Licari, Amelia Salpietro, Carmelo Miraglia del Giudice, Michele Marseglia, Gian Luigi Leonardi, Salvatore Ital J Pediatr Research BACKGROUND: Recurrent respiratory infections (RRIs) are defined by the presence of at least one of the following criteria: (i) > 6 annual respiratory infections (RIs); (ii) > 1 monthly RIs involving the upper airways from September to April; (iii) > 3 annual RIs involving the lower airways represent a very common health problem in the first years of life. We conducted a multi-centre, prospective, single-open study to assess the efficacy and the safety of Streptococcus salivarius 24SMBc and Streptococcus oralis 89a in the prevention of upper respiratory tract infections (URTIs) in children. METHODS: Ninety-one children (M:F = 47:44, mean age 7.4 ± 2.3 years) with RRIs were enrolled in the study between September and November 2018. At baseline, children received Streptococcus salivarius 24SMBc and Streptococcus oralis 89a as 2 puffs for nostril twice/day for 7 days/months. The treatment lasted for 3 consecutive months. Efficacy was expressed in terms of absence or presence of fever, cough, bronchospasm, rhinorrhea and otalgia, at 1 month (T1), and 3 (T3) months. Safety and tolerability of the probiotic were evaluated on the basis of the number and type of adverse events (AEs) recorded during the treatment. RESULTS: Children treated with Streptococcus salivarius 24SMBc and Streptococcus oralis 89a showed a significant decrease of symptoms including episodes of fever, cough, bronchospasm, rhinorrhea, and otalgia (p < 0.001) compared to baseline. The treatment significantly reduced the number of episodes of fever, cough, bronchospasm, rhinorrhea, otalgia, and cough also in patients with positive familial history for atopy and in atopic children (p < 0.05). No significant differences in symptoms among children with negative familial history for atopy and children with positive familial history for atopy subgroups, not atopic and atopic children subgroups, and smoke-exposed and not smoke-exposed subgroups were observed (p > 0.05). Conducting a subgroup analysis according to the age, it has been reported that children aged 1–3 years old showed an improvement in all symptoms, however, they become statistically significant only at the end of the 3 months of treatment (p < 0.05). Conversely, in children aged 3–6 and 6–12 years old, the therapeutic efficacy was progressive and significant already from the first month of therapy (p < 0.05). None of the children were withdrawn from the study because of AEs, although 9 children experienced burning nose leading to interruption of therapy. CONCLUSIONS: Our findings suggest that Streptococcus salivarius 24SMBc and Streptococcus oralis 89a treatment is safe and seems to be effective on short-term in the treatment of RRIs. Studies involving a longer observation period are necessary to establish the real efficacy of the product for the treatment of pediatric patients affected by RRIs. BioMed Central 2020-04-03 /pmc/articles/PMC7126168/ /pubmed/32245500 http://dx.doi.org/10.1186/s13052-020-0798-4 Text en © The Author(s). 2020 Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
spellingShingle Research
Manti, Sara
Parisi, Giuseppe Fabio
Papale, Maria
Licari, Amelia
Salpietro, Carmelo
Miraglia del Giudice, Michele
Marseglia, Gian Luigi
Leonardi, Salvatore
Bacteriotherapy with Streptococcus salivarius 24SMB and Streptococcus oralis 89a nasal spray for treatment of upper respiratory tract infections in children: a pilot study on short-term efficacy
title Bacteriotherapy with Streptococcus salivarius 24SMB and Streptococcus oralis 89a nasal spray for treatment of upper respiratory tract infections in children: a pilot study on short-term efficacy
title_full Bacteriotherapy with Streptococcus salivarius 24SMB and Streptococcus oralis 89a nasal spray for treatment of upper respiratory tract infections in children: a pilot study on short-term efficacy
title_fullStr Bacteriotherapy with Streptococcus salivarius 24SMB and Streptococcus oralis 89a nasal spray for treatment of upper respiratory tract infections in children: a pilot study on short-term efficacy
title_full_unstemmed Bacteriotherapy with Streptococcus salivarius 24SMB and Streptococcus oralis 89a nasal spray for treatment of upper respiratory tract infections in children: a pilot study on short-term efficacy
title_short Bacteriotherapy with Streptococcus salivarius 24SMB and Streptococcus oralis 89a nasal spray for treatment of upper respiratory tract infections in children: a pilot study on short-term efficacy
title_sort bacteriotherapy with streptococcus salivarius 24smb and streptococcus oralis 89a nasal spray for treatment of upper respiratory tract infections in children: a pilot study on short-term efficacy
topic Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7126168/
https://www.ncbi.nlm.nih.gov/pubmed/32245500
http://dx.doi.org/10.1186/s13052-020-0798-4
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