Study of Lacticaseibacillus rhamnosus CRL1505 to Prevent Upper Respiratory Infections in Healthy Children Aged 3 to 12 Years

What this Trial Is About

Researchers are evaluating the effects of a probiotic called Lacticaseibacillus rhamnosus CRL1505 on preventing or reducing upper respiratory tract infections URTIs in healthy children aged 3 to 12 years. This clinical trial is randomized, double-blind, and placebo-controlled to ensure reliable results. The study focuses on a pediatric population during the winter months when URTIs are most common, aiming to assess both the safety and effectiveness of the probiotic strain in this group. Participants will be randomly assigned to one of two groups one receiving the probiotic and the other a placebo, both given as 2g sticks with similar appearance. The intervention period lasts 12 weeks, followed by an additional 4-week post-treatment follow-up, totaling 16 weeks. During the study, participants should maintain their usual diet and physical activity without changes. Parents will be responsible for daily monitoring and will complete an online questionnaire to record symptoms, safety, and other health data. Researchers will assess the number and severity of URTI episodes, use of medications, school absences, and other health outcomes at 12 and 16 weeks. This careful tracking helps evaluate how the probiotic may influence URTI prevention and recovery in children.

Clinical Trial to Evaluate the Efficacy of Lacticaseibacillus Rhamnosus CRL1505 in the Prevention of Upper Respiratory Tract Infections in Children