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

Condition(s) studied

Investigational drug(s) / intervention(s)

Probiotic - Lacticaseibacillus rhamnosus CRL1505: The probiotic product is provided in 2g sticks containing the strain Lacticaseibacillus rhamnosus CRL1505 at a concentration of ≥ 1.0E+8 CFU/g, with corn starch and maltodextrin as excipients.

Placebo: The placebo product is provided in 2g sticks of corn starch and maltodextrin.

Study summary

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 paediatric population.

Eligibility

Primary outcome measure(s)

• Patients who were diagnosed with at least 1, 2 or 3 URTIs — 12 and 16 weeks
  Difference in the proportion of patients who were diagnosed with at least 1, 2 or 3 URTIs during the intervention (12 weeks) and follow-up period (16 weeks) between the study groups
• Number of URTIs per patient — 12 and 16 weeks
  Difference in the mean number of URTIs per patient between the study groups during the intervention period (12 weeks) and follow-up period (16 weeks)
• Patients who were diagnosed of common cold and influenza — 12 and 16 weeks
  Difference in the proportion of patients who were diagnosed of common cold and influenza during the intervention (12 weeks) and follow-up period (16 weeks) between the study groups. \*This analysis will only be performed if a considerable number of URTIs other than the common cold are recorded.

Trial sites (1)

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