RecruitingNot ApplicableNCT07154992

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

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 Paediatric Population

Sponsor

Bioithas SL

Enrollment

268 participants

Start Date

Dec 17, 2024

Study Type

INTERVENTIONAL

Conditions

Prevention Upper respiratory tract infection

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

Min Age: 3 YearsMax Age: 12 Years

Inclusion Criteria2

Healthy children aged 3 to 12 years.
Signed Informed Consent by the parents

Exclusion Criteria5

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.
Regular use of medications or dietary supplements that may influence the study outcomes (immunosuppressants/immunostimulants, including echinacea supplements, analgesics, anti-inflammatory drugs, antitussives/expectorants, flu preparations, decongestants, antibiotics, antihistamines, probiotics, etc.) within the 4 weeks prior to the start of the clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DIETARY_SUPPLEMENTProbiotic - 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.

DIETARY_SUPPLEMENTPlacebo

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