Streptococcus salivarius Probiotics to Prevent Acute Otitis Media in Children

{ 'indexed': {'date-parts': [[2023, 11, 3]], 'date-time': '2023-11-03T00:55:50Z', 'timestamp': 1698972950666}, 'reference-count': 32, 'publisher': 'American Medical Association (AMA)', 'issue': '11', 'content-domain': {'domain': [], 'crossmark-restriction': False}, 'abstract': '<jats:sec><jats:title>Importance</jats:title><jats:p>New approaches for the prevention of ' 'acute otitis media (AOM), the most common reason for antibiotic use in children, are ' 'needed.</jats:p></jats:sec><jats:sec><jats:title>Objective</jats:title><jats:p>To assess the ' 'efficacy of the <jats:italic>Streptococcus salivarius</jats:italic> K12 oral probiotics in ' 'the primary prevention of AOM.</jats:p></jats:sec><jats:sec><jats:title>Design, Setting, and ' 'Participants</jats:title><jats:p>This double-blind, randomized placebo-controlled clinical ' 'trial was conducted from August 1, 2020, to May 31, 2021, at 50 day care centers in the Oulu ' 'region of Finland. A total of 827 children aged 1 to 6 years attending day care were ' 'included. The exclusion criteria consisted of ongoing antimicrobial prophylaxis or ' 'immunodeficiency. The follow-up time was 6 months and was completed on May 31, 2021. Data ' 'were analyzed from October 24, 2022, to September 16, 2023, based on intention to ' 'treat.</jats:p></jats:sec><jats:sec><jats:title>Intervention</jats:title><jats:p>Eligible ' 'participants were randomly allocated to receive 1 daily dose of a <jats:italic>S ' 'salivarius</jats:italic> K12 product or placebo every evening for 6 months. A daily dose was ' 'defined as 1 sachet of soluble oral powder for children younger than 3 years or 1 chewable ' 'tablet for children 3 years or older containing 1\u2009×\u200910<jats:sup>9</jats:sup> ' 'colony-forming units of <jats:italic>S salivarius</jats:italic> ' 'K12.</jats:p></jats:sec><jats:sec><jats:title>Main Outcomes and ' 'Measures</jats:title><jats:p>The primary outcome was the proportion of children with at least ' '1 episode of AOM requiring antimicrobial therapy within 6 months of randomization. All ' 'physician visits and purchases of antimicrobial drugs were retrieved from the electronic ' 'national medical record and prescription register. The primary outcome was met if the legal ' 'guardian had purchased an antimicrobial prescription for ' 'AOM.</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>A total of 827 ' 'children with a mean (SD) age of 4.1 (1.6) years (433 boys [52.4%]) were randomized to ' '<jats:italic>S salivarius</jats:italic> K12 oral products (n\u2009=\u2009413) or placebo ' '(n\u2009=\u2009414). Thirty-four children (8.2%) in the <jats:italic>S ' 'salivarius</jats:italic> group and 24 children (5.8%) in the placebo group experienced at ' 'least 1 episode of AOM requiring antimicrobial therapy during the 6-month follow-up period ' '(relative risk, 1.42 [95% CI, 0.86-2.34]; proportion difference, −2.44% [95% CI, −5.94% to ' '1.09%]; <jats:italic>P</jats:italic>\u2009=\u2009.17). Time to first AOM episode did not ' 'differ between the groups (174 [95% CI, 171-177] days in the <jats:italic>S ' 'salivarius</jats:italic> group vs 176 [95% CI, 173-179] days in the placebo group; ' '<jats:italic>P</jats:italic>\u2009=\u2009' '.18).</jats:p></jats:sec><jats:sec><jats:title>Conclusions and ' 'Relevance</jats:title><jats:p>In this randomized placebo-controlled clinical trial, the daily ' 'use of the <jats:italic>S salivarius</jats:italic> K12 products for 6 months did not reduce ' 'the occurrence of AOM. New approaches for primary prevention of AOM among children are ' 'needed.</jats:p></jats:sec><jats:sec><jats:title>Trial ' 'Registration</jats:title><jats:p>ClinicalTrialsRegister.eu Identifier: <jats:ext-link ' 'xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="uri" ' 'xlink:href="https://www.clinicaltrialsregister.eu/ctr-search/search?query=2020-001076-14">2020-001076-14</jats:ext-link></jats:p></jats:sec>', 'DOI': '10.1001/jamanetworkopen.2023.40608', 'type': 'journal-article', 'created': {'date-parts': [[2023, 11, 2]], 'date-time': '2023-11-02T15:36:01Z', 'timestamp': 1698939361000}, 'page': 'e2340608', 'source': 'Crossref', 'is-referenced-by-count': 0, 'title': '<i>Streptococcus salivarius</i> Probiotics to Prevent Acute Otitis Media in Children', 'prefix': '10.1001', 'volume': '6', 'author': [ { 'given': 'Suvi', 'family': 'Sarlin', 'sequence': 'first', 'affiliation': [ { 'name': 'Department of Pediatrics and Adolescent Medicine and Medical ' 'Research Center, Oulu University Hospital, Oulu, Finland'}, { 'name': 'Research Unit of Clinical Medicine, University of Oulu, Oulu, ' 'Finland'}]}, { 'given': 'Ulla', 'family': 'Koskela', 'sequence': 'additional', 'affiliation': [ { 'name': 'Department of Pediatrics and Adolescent Medicine and Medical ' 'Research Center, Oulu University Hospital, Oulu, Finland'}, { 'name': 'Research Unit of Clinical Medicine, University of Oulu, Oulu, ' 'Finland'}]}, { 'given': 'Minna', 'family': 'Honkila', 'sequence': 'additional', 'affiliation': [ { 'name': 'Department of Pediatrics and Adolescent Medicine and Medical ' 'Research Center, Oulu University Hospital, Oulu, Finland'}, { 'name': 'Research Unit of Clinical Medicine, University of Oulu, Oulu, ' 'Finland'}]}, { 'given': 'Paula A.', 'family': 'Tähtinen', 'sequence': 'additional', 'affiliation': [ { 'name': 'Department of Paediatrics and Adolescent Medicine, Turku ' 'University Hospital and University of Turku, Turku, Finland'}]}, { 'given': 'Tytti', 'family': 'Pokka', 'sequence': 'additional', 'affiliation': [ { 'name': 'Research Unit of Clinical Medicine, University of Oulu, Oulu, ' 'Finland'}, {'name': 'Research Service Unit, Oulu University Hospital, Oulu, Finland'}]}, { 'given': 'Marjo', 'family': 'Renko', 'sequence': 'additional', 'affiliation': [ { 'name': 'Department of Pediatrics, Kuopio University Hospital and ' 'University of Eastern Finland, Kuopio, Finland'}]}, { 'given': 'Terhi', 'family': 'Tapiainen', 'sequence': 'additional', 'affiliation': [ { 'name': 'Department of Pediatrics and Adolescent Medicine and Medical ' 'Research Center, Oulu University Hospital, Oulu, Finland'}, { 'name': 'Research Unit of Clinical Medicine, University of Oulu, Oulu, ' 'Finland'}]}], 'member': '10', 'published-online': {'date-parts': [[2023, 11, 2]]}, 'reference': [ { 'issue': '3', 'key': 'zoi231183r1', 'doi-asserted-by': 'publisher', 'first-page': '375', 'DOI': '10.1542/peds.2013-2903', 'article-title': 'Recent trends in outpatient antibiotic 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