Randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy and safety of Lacticaseibacillus rhamnosus CRL1505 in the prevention of upper respiratory tract infections in a healthy pediatric population

Randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy and safety of Lacticaseibacillus rhamnosus CRL1505 in the prevention of upper respiratory tract infections in a healthy pediatric population

Identifiers

URI: http://hdl.handle.net/10952/8970

Files

Registro IRESP.PROB 2.pdf (171.75 KB)

Publication date

2024-12

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Abstract

Randomized, double-blind, placebo-controlled, parallel-group, clinical trial to assess the efficacy of the intake of a probiotic product composed of Lacticaseibacillus rhamnosus CRL1505 strain in reducing or preventing upper respiratory tract infections (URTIs) in a healthy pediatric population.

Description

Randomized, double-blind, placebo-controlled, parallel-group, clinical trial. The study aims to demonstrate the efficacy of the intake of a probiotic product composed of Lacticaseibacillus rhamnosus CRL1505 strain in reducing or preventing upper respiratory tract infections in a healthy pediatric population. The clinical trial has an intervention period of 12 weeks and a post-treatment follow-up period of 4 additional weeks (16 weeks in total). The study aims to demonstrate the efficacy and safety of consuming the probiotic strain Lacticaseibacillus rhamnosus CRL1505 in the prevention and reduction of the severity and duration of URTI (upper respiratory tract infections) episodes in a healthy pediatric population. A total of 268 participants aged 3 to 12 years will be recruited and randomized into two treatment groups in a 1:1 ratio (134 participants in the PROBIOTIC GROUP and 134 participants in the PLACEBO GROUP). The two intervention groups will differ based on the treatment received: probiotic or placebo, both of which will have a similar appearance.