Status:
RECRUITING
Clinical Trial to Evaluate the Efficacy of Lacticaseibacillus Rhamnosus CRL1505 in the Prevention of Upper Respiratory Tract Infections in Children
Lead Sponsor:
Bioithas SL
Collaborating Sponsors:
Centro Sperimentale del Latte S.r.l.
Conditions:
Upper Respiratory Tract Infection
Prevention
Eligibility:
All Genders
3-12 years
Phase:
NA
Brief 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 redu...
Detailed 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 ...
Eligibility Criteria
Inclusion
- Healthy children aged 3 to 12 years.
- Signed Informed Consent by the parents
Exclusion
- 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.
Key Trial Info
Start Date :
December 17 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2027
Estimated Enrollment :
268 Patients enrolled
Trial Details
Trial ID
NCT07154992
Start Date
December 17 2024
End Date
April 1 2027
Last Update
September 12 2025
Active Locations (1)
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1
MiBioPath Research Group (UCAM)
Murcia, Spain