# 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

## TL;DR

A food supplement reduced the frequency and severity of respiratory infections in children aged 3–10 years, with fewer illness days and less need for medication.

## Contribution

A novel immune-boosting supplement combining vitamins, minerals, herbal extracts, and a probiotic was shown to reduce pediatric RTI frequency and severity.

## Key findings

- The supplement significantly reduced RTI episodes compared to placebo.
- Children taking the supplement had fewer illness days and reduced use of antipyretics and antibiotics.
- The supplement was well-tolerated and showed a significant reduction in RTI severity.

## Abstract

What are the main findings?
The food supplement significantly reduced the number of respiratory tract infection (RTI) episodes in children aged 3–10 years compared with the placebo.The supplement also reduced RTI severity, as shown by fewer illness days, fewer days with fever, cough, and rhinitis, and reduced use of antipyretics and antibiotics, with good tolerability.

The food supplement significantly reduced the number of respiratory tract infection (RTI) episodes in children aged 3–10 years compared with the placebo.

The supplement also reduced RTI severity, as shown by fewer illness days, fewer days with fever, cough, and rhinitis, and reduced use of antipyretics and antibiotics, with good tolerability.

What are the implications of the main findings?
Supplementation with a combination of vitamins, minerals, herbal extracts, and Lactobacillus rhamnosus CRL1505 may be an effective preventive strategy for reducing both the frequency and severity of pediatric RTIs.This approach could help lower healthcare use and the socioeconomic burden associated with recurrent RTIs in children.

Supplementation with a combination of vitamins, minerals, herbal extracts, and Lactobacillus rhamnosus CRL1505 may be an effective preventive strategy for reducing both the frequency and severity of pediatric RTIs.

This approach could help lower healthcare use and the socioeconomic burden associated with recurrent RTIs in children.

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® 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. 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 ± 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. Conclusions: The patented supplementation based on vitamins, minerals, herbal extracts, and Lactobacillus rhamnosus CRL1505 (Pegaso® Immuno Junior), taken over a three-month period, may reduce the frequency and severity of RTIs in children aged 3–10 years.