About this trial
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 criteria
Qualifiers
Healthy children aged 3 to 12 years.
Signed Informed Consent by the parents
Disqualifiers
Chronic pathological conditions, such as chronic respiratory diseases (asthma, chronic bronchitis, etc.), chronic heart diseases, chronic neurological diseases (psychomotor impairment, etc.), chronic liver diseases, chronic kidney diseases, chronic gastrointestinal diseases, hematological disorders, etc., or any other disease or condition that the investigator considers to significantly affect the health of the participating child.
Metabolic disorders, such as diabetes mellitus, obesity, etc.
Immunodeficiency, including HIV infection, chronic corticosteroid treatment, etc.
Nasal polyps, nasal ulcers, or other conditions that may cause nasal obstruction.
Trial design
Treatments tested in this trial
- Probiotic - Lacticaseibacillus rhamnosus CRL1505
- Placebo
Treatment groups
Sponsors and collaborators
Bioithas SL
Lead sponsor
Centro Sperimentale del Latte S.r.l.
Collaborator