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.
Healthy children aged 3 to 12 years.
Signed Informed Consent by the parents
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.
Parallel
Probiotic - Lacticaseibacillus rhamnosus CRL1505
Dietary supplementThe 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
Dietary supplementThe placebo product is provided in 2g sticks of corn starch and maltodextrin.
Patients who were diagnosed with at least 1, 2 or 3 URTIs
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
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
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.
Participants who presented URTI complications
Difference in the proportion of participants who experienced URTI complications (bacterial superinfections such as pneumonia, otitis media, and acute sinusitis) during the intervention period (12 weeks) and the total follow-up period (16 weeks) between the study groups.
Number of days with a URTI episode per participant
Difference in the average number of days with a URTI episode per participant (days with URTI/participants) during the intervention period (12 weeks) and the total follow-up period (16 weeks) between the study groups.
Number of days until the first URTI
Difference in the average number of days until the onset of the first URTI episode during the intervention period (12 weeks) between the study groups.
Duration of each URTI episode
Difference in the average duration of each URTI episode (mean ratio of days with URTI/URTI episodes for each participant) during the intervention period (12 weeks) and the total follow-up period (16 weeks) between the study groups.
Incidence and severity of all Adverse Events
* Incidence and severity of all Adverse Events. * Incidence of Severe Adverse Events. * Incidence and severity of Adverse Events related to the study product. * Incidence and severity of Adverse Events leading to study withdrawal. * Rate of withdrawal due to intolerance to study product.
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Bioithas SL
Lead sponsor
Centro Sperimentale del Latte S.r.l.
Collaborator
