{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,12]],"date-time":"2026-09-12T03:07:31Z","timestamp":1789182451932,"version":"build-2803163510"},"reference-count":29,"publisher":"Springer Science and Business Media LLC","issue":"9","license":[{"start":{"date-parts":[[2026,9,3]],"date-time":"2026-09-03T00:00:00Z","timestamp":1788393600000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2026,9,3]],"date-time":"2026-09-03T00:00:00Z","timestamp":1788393600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"DOI":"10.13039\/100008247","name":"University of Otago","doi-asserted-by":"crossref","id":[{"id":"10.13039\/100008247","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Eur J Pediatr"],"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>\n                    Acute otitis media (AOM) and respiratory tract infections are common in early childhood and are major contributors to antibiotic use. The oral probiotic\n                    <jats:italic>Streptococcus salivarius<\/jats:italic>\n                    K12 has demonstrated antimicrobial and immunomodulatory activity in vitro, and preventive effects in children with recurrent AOM. We aim to determine the efficacy of\n                    <jats:italic>S. salivarius K12<\/jats:italic>\n                    in preventing AOM in the general infant population. We conducted a multicentre, double-blind, randomised, placebo-controlled trial in Wellington and Christchurch, New Zealand. Children were enrolled at 3\u20136 months of age, their households were randomised 1:1, and daily study product was given from age 6 to 24 months. The primary outcome was the rate of doctor-recorded AOM. Secondary outcomes included time to first AOM episode, respiratory infections, antibiotic prescribing and healthcare utilisation. Analyses were by intention to treat using mixed-effects negative binomial regression adjusted for region and, for the primary outcome, prior AOM, with random effects for general practice and family. A total of 428 children were randomised by household and 368 (86%) contributed primary outcome data (placebo\n                    <jats:italic>n<\/jats:italic>\n                    \u2009=\u2009180; active\n                    <jats:italic>n<\/jats:italic>\n                    \u2009=\u2009188). Doctor-recorded AOM occurred in 70\/180 (39%) placebo recipients and 70\/188 (37%) probiotic recipients (rate ratio 0.84, 95% CI 0.57\u20131.24). Time to first AOM episode did not significantly differ (hazard ratio 0.89, 95% CI 0.63\u20131.26). No significant differences were observed for AOM severity, respiratory infections, antibiotic prescribing or healthcare utilisation. Higher-adherence analyses were also not statistically significant.\n                  <\/jats:p>\n                  <jats:p>\n                    <jats:italic>Conclusions:<\/jats:italic>\n                    Daily oral\n                    <jats:italic>S. salivarius<\/jats:italic>\n                    K12 did not reduce AOM incidence or respiratory infections in children under 2 years; therefore, routine use for AOM prevention in general paediatric populations is not supported.\n                  <\/jats:p>\n                  <jats:p>\n                    <jats:italic>Trial registration:<\/jats:italic>\n                    Australian New Zealand Clinical Trials Registry\u2014ACTRN12618000130268; prospectively registered on 30 January 2018, before enrolment of the first participant on 24 August 2018.\n                    <jats:table-wrap>\n                      <jats:table>\n                        <jats:tbody>\n                          <jats:tr>\n                            <jats:td colspan=\"2\">\n                              <jats:bold>What is Known:<\/jats:bold>\n                              \u2022\n                              <jats:italic>Streptococcus salivarius K12 is a naturally occurring oral probiotic and has demonstrated antimicrobial and immunomodulatory activity in vitro, and preventive effects in children with recurrent AOM.<\/jats:italic>\n                            <\/jats:td>\n                          <\/jats:tr>\n                          <jats:tr>\n                            <jats:td colspan=\"2\">\n                              <jats:bold>What is New:<\/jats:bold>\n                              \u2022\u00a0\n                              <jats:italic>Whether there are preventative effects of daily use for AOM and respiratory infections in infants from the general population.<\/jats:italic>\n                            <\/jats:td>\n                          <\/jats:tr>\n                        <\/jats:tbody>\n                      <\/jats:table>\n                    <\/jats:table-wrap>\n                  <\/jats:p>","DOI":"10.1007\/s00431-026-07379-3","type":"journal-article","created":{"date-parts":[[2026,9,3]],"date-time":"2026-09-03T18:52:02Z","timestamp":1788461522000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Preventing otitis media and respiratory tract infections with the oral probiotic Streptococcus salivarius K12"],"prefix":"10.1007","volume":"185","author":[{"given":"Caroline","family":"Halley","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Claire","family":"Honeywill","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Janice","family":"Kang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Phillipa","family":"Barnes","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gordon","family":"Purdie","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gwyneth","family":"Steenson","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rae","family":"Noble-Adams","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Thorsten","family":"Stanley","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kathryn","family":"Fuge","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lynn","family":"McBain","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ben","family":"Hudson","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Julian","family":"Crane","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2026,9,3]]},"reference":[{"key":"7379_CR1","unstructured":"Food and Agriculture Organization of the United Nations (FAO) and World Health Organization (WHO) (2001) Health and nutritional properties of probiotics in food including powder milk with live lactic acid bacteria: Report of a Joint FAO\/WHO Expert Consultation on Evaluation of Health and Nutritional Properties of Probiotics in Food Including Powder Milk with Live Lactic Acid Bacteria. C\u00f3rdoba, Argentina, 1\u20134 October 2001"},{"issue":"4","key":"7379_CR2","doi-asserted-by":"publisher","first-page":"527","DOI":"10.1093\/infdis\/128.4.527","volume":"128","author":"CC Crowe","year":"1973","unstructured":"Crowe CC, Sanders WE Jr, Longley S (1973) Bacterial interference. II. Role of the normal throat flora in prevention of colonization by group A Streptococcus. J Infect Dis 128(4):527\u2013532. https:\/\/doi.org\/10.1093\/infdis\/128.4.527","journal-title":"J Infect Dis"},{"issue":"5","key":"7379_CR3","doi-asserted-by":"publisher","first-page":"683","DOI":"10.1093\/infdis\/146.5.683","volume":"146","author":"CC Sanders","year":"1982","unstructured":"Sanders CC, Sanders WE Jr. (1982) Enocin: an antibiotic produced by Streptococcus salivarius that may contribute to protection against infections due to group A streptococci. J Infect Dis 146(5):683\u2013690. https:\/\/doi.org\/10.1093\/infdis\/146.5.683","journal-title":"J Infect Dis"},{"issue":"4","key":"7379_CR4","doi-asserted-by":"publisher","first-page":"1107","DOI":"10.1128\/AEM.02265-06","volume":"73","author":"O Hyink","year":"2007","unstructured":"Hyink O, Wescombe PA, Upton M, Ragland N, Burton JP, Tagg JR (2007) 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 73(4):1107\u20131113. https:\/\/doi.org\/10.1128\/AEM.02265-06","journal-title":"Appl Environ Microbiol"},{"key":"7379_CR5","doi-asserted-by":"publisher","first-page":"819","DOI":"10.2217\/fmb.09.61","volume":"4","author":"PA Wescombe","year":"2009","unstructured":"Wescombe PA, Heng NC, Burton JP, Chilcott CN, Tagg JR (2009) Streptococcal bacteriocins and the case for Streptococcus salivarius as model oral probiotics. 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Participants were informed of the study\u2019s purpose, risks, and benefits, and a consent-to-participate declaration was completed. Written informed consent was obtained from all caregivers\/parents prior to their child\u2019s participation. Ethical approval was granted by the Health and Disability Ethics Committee (HDEC) (Approval number: 16\/CEN\/190). Consultation was undertaken with the Ng\u0101i Tahu Research Consultation Committee (NTRCC) to ensure culturally safe practice in alignment with the principles of Te Tiriti o Waitangi.","order":1,"name":"Ethics","label":"Ethics approval","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"The authors declare no competing interests.","order":2,"name":"Ethics","label":"Competing interestst","group":{"name":"EthicsHeading","label":"Declarations"}}],"article-number":"718"}}