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

<b>Background</b>: 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. <b>Methods</b>: 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 <i>Lactobacillus rhamnosus</i> CRL1505 (Pegaso^® Immuno Junior). A daily dose was administered for approximately 60 days within a three-month period to children aged 3-10 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. <b>Results</b>: 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 ± 0.84 vs. 4.13 ± 1.66; RR = 0.745, 95% CI 0.583-0.953) 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. <b>Conclusions</b>: The patented supplementation based on vitamins, minerals, herbal extracts, and <i>Lactobacillus rhamnosus</i> CRL1505 (Pegaso^® Immuno Junior), taken over a three-month period, may reduce the frequency and severity of RTIs in children aged 3-10 years.