{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,20]],"date-time":"2026-03-20T12:18:20Z","timestamp":1774009100907,"version":"3.50.1"},"reference-count":45,"publisher":"MDPI AG","issue":"3","license":[{"start":{"date-parts":[[2026,3,20]],"date-time":"2026-03-20T00:00:00Z","timestamp":1773964800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Schwabe Pharma Italia under agreement with the Azienda Ospedaliera Provinciale of Messina"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Children"],"abstract":"<jats:p>Background: Respiratory tract infections (RTIs) are common in children and represent one of the main reasons for pediatric consultations. Although generally benign, pediatric RTIs can lead to medical complications and significant socioeconomic burden. The objective of this trial was to evaluate the efficacy of a food supplement intended to support the immune system in reducing the rate and severity of pediatric RTIs. Methods: A randomized, double-blind, placebo-controlled, parallel-group clinical trial was conducted to assess the efficacy and safety of a food supplement based on vitamins, minerals, herbal extracts, and Lactobacillus rhamnosus CRL1505 (Pegaso\u00ae Immuno Junior). A daily dose was administered for approximately 60 days within a three-month period to children aged 3\u201310 years with at least four RTI episodes in the previous year. RTI frequency, illness days, days with fever, cough, and rhinitis, and antipyretic and antibiotic use per episode were recorded over four months. Results: A total of 110 children completed the study. Compared with the placebo, the active supplement significantly reduced the mean number of RTI episodes per child (2.41 \u00b1 0.84 vs. 4.13 \u00b1 1.66; RR = 0.745, 95% CI 0.583\u20130.953) as well as the number of illness days, days with fever, cough, and rhinitis, and days with antipyretic or antibiotic use. The supplement was well-tolerated. Conclusions: The patented supplementation based on vitamins, minerals, herbal extracts, and Lactobacillus rhamnosus CRL1505 (Pegaso\u00ae Immuno Junior), taken over a three-month period, may reduce the frequency and severity of RTIs in children aged 3\u201310 years.<\/jats:p>","DOI":"10.3390\/children13030428","type":"journal-article","created":{"date-parts":[[2026,3,20]],"date-time":"2026-03-20T09:44:41Z","timestamp":1773999881000},"page":"428","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Evaluation of the Effects of an Immune-Boosting Food Supplement on the Severity and Frequency of Pediatric Respiratory Tract Infections: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial"],"prefix":"10.3390","volume":"13","author":[{"given":"Fabrizio","family":"Calapai","sequence":"first","affiliation":[{"name":"Department of Clinical and Experimental Medicine, University of Messina, 98166 Messina, Italy"},{"name":"Department of Biomedical, Dental, Morphological and Functional Imaging Sciences, University of Messina, 98125 Messina, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4075-8065","authenticated-orcid":false,"given":"Ilaria","family":"Ammendolia","sequence":"additional","affiliation":[{"name":"Department of Clinical and Experimental Medicine, University of Messina, 98166 Messina, Italy"},{"name":"Department of Chemical, Biological, Pharmaceutical and Environmental Sciences, University of Messina, 98166 Messina, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1292-6284","authenticated-orcid":false,"given":"Carmen","family":"Mannucci","sequence":"additional","affiliation":[{"name":"Department of Biomedical, Dental, Morphological and Functional Imaging Sciences, University of Messina, 98125 Messina, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0009-0001-9062-2932","authenticated-orcid":false,"given":"Giorgia","family":"Bulferi","sequence":"additional","affiliation":[{"name":"Regulatory and Scientific Affairs Department, Schwabe Pharma Italia, 39044 Egna, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Lara","family":"Pauletto","sequence":"additional","affiliation":[{"name":"Regulatory and Scientific Affairs Department, Schwabe Pharma Italia, 39044 Egna, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3544-0108","authenticated-orcid":false,"given":"Heide De","family":"Togni","sequence":"additional","affiliation":[{"name":"Regulatory and Scientific Affairs Department, Schwabe Pharma Italia, 39044 Egna, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Rita","family":"La Paglia","sequence":"additional","affiliation":[{"name":"Italian National Health Service, Azienda Sanitaria Provinciale 5, 98123 Messina, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Floriana","family":"Raso","sequence":"additional","affiliation":[{"name":"Associazione Farmaceutici Industria, 20149 Milano, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mariaconcetta","family":"Curr\u00f2","sequence":"additional","affiliation":[{"name":"Department of Clinical and Experimental Medicine, University of Messina, 98166 Messina, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8116-4821","authenticated-orcid":false,"given":"Gioacchino","family":"Calapai","sequence":"additional","affiliation":[{"name":"Department of Chemical, Biological, Pharmaceutical and Environmental Sciences, University of Messina, 98166 Messina, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"1968","published-online":{"date-parts":[[2026,3,20]]},"reference":[{"key":"ref_1","first-page":"k2698","article-title":"Recurrent lower respiratory tract infections in children","volume":"362","author":"Bush","year":"2018","journal-title":"BMJ"},{"key":"ref_2","doi-asserted-by":"crossref","unstructured":"Jiang, X., Sun, L., Wang, B., Yang, X., Shang, L., and Zhang, Y. 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