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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Bioithas SL
- Enrollment
- 268
- Locations
- 1
- Primary Endpoint
- Patients who were diagnosed with at least 1, 2 or 3 URTIs
Study Overview
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 reducing or preventing upper respiratory tract infections (URTIs) in a healthy paediatric population.
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 CRL1505 strain in reducing or preventing upper respiratory tract infections in a healthy paediatric population.
The clinical trial has an intervention period of 12 weeks and a post-treatment follow-up period of 4 additional weeks (16 weeks in total).
The study aims to demonstrate the efficacy and safety of consuming the probiotic strain Lacticaseibacillus rhamnosus CRL1505 in the prevention and reduction of the severity and duration of URTI (upper respiratory tract infections) episodes in a healthy paediatric population.
A total of 268 participants aged 3 to 12 years will be recruited and randomized into two treatment groups in a 1:1 ratio (134 participants in the PROBIOTIC GROUP and 134 participants in the PLACEBO GROUP). The two intervention groups will differ based on the treatment received: probiotic or placebo, both of which will have a similar appearance.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 3 Years to 12 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Healthy children aged 3 to 12 years.
- •Signed Informed Consent by the parents
Exclusion Criteria
- •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.
Arms & Interventions
PLACEBO
Intervention: Placebo (Dietary Supplement)
PROBIOTIC
Intervention: Probiotic - Lacticaseibacillus rhamnosus CRL1505 (Dietary Supplement)
Outcomes
Primary Outcomes
Patients who were diagnosed with at least 1, 2 or 3 URTIs
Time Frame: 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
Time Frame: 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
Time Frame: 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.
Secondary Outcomes
- Number of days until the first URTI(12 weeks)
- Participants who presented URTI complications(12 and 16 weeks)
- Number of days with a URTI episode per participant(12 and 16 weeks)
- Duration of each URTI episode(12 and 16 weeks)
- URTI-free time rate(12 and 16 weeks)
- Score of each symptom evaluated on the Jackson scale(12 and 16 weeks)
- Number of days with fever per participant(12 and 16 weeks)
- Participants who received antibiotic treatment(12 and 16 weeks)
- Number of days with antibiotic treatment per participant(12 and 16 weeks)
- Proportion of URTI episodes in which participants received symptomatic medication(12 and 16 weeks)
- Proportion of URTI days in which participants received symptomatic medication(12 and 16 weeks)
- Participants who experienced gastrointestinal infections(12 and 16 weeks)
- School absence rate(12 and 16 weeks)
- Participants who presented URTI complications(12 and 16 weeks)
- Number of days with a URTI episode per participant(12 and 16 weeks)
- Number of days until the first URTI(12 weeks)
- Duration of each URTI episode(12 and 16 weeks)
- URTI-free time rate(12 and 16 weeks)
- Score of each symptom evaluated on the Jackson scale(12 and 16 weeks)
- Number of days with fever per participant(12 and 16 weeks)
- Participants who received antibiotic treatment(12 and 16 weeks)
- Number of days with antibiotic treatment per participant(12 and 16 weeks)
- Proportion of URTI episodes in which participants received symptomatic medication(12 and 16 weeks)
- Proportion of URTI days in which participants received symptomatic medication(12 and 16 weeks)
- Participants who experienced gastrointestinal infections(12 and 16 weeks)
- School absence rate(12 and 16 weeks)