Clinical Trial to Evaluate the Efficacy of Lacticaseibacillus Rhamnosus CRL1505 in the Prevention of Upper Respiratory Tract Infections in Children
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Probiotic - Lacticaseibacillus rhamnosus CRL1505, Placebo.
- Who it may be relevant to
- Registry conditions: Upper Respiratory Tract Infection, Prevention. Basic parameters: 3 years — 12 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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.
The study will focus on a healthy paediatric population; therefore, the exclusion criteria will eliminate children with significant acute or chronic diseases and those with an immunocompromised condition. Additionally, children receiving continuous pharmacological treatment or those who have consumed dietary supplements that could influence the study results within the four weeks prior to inclusion will be excluded. However, if these children can discontinue such treatments, they may participate in the clinical trial after a washout period. Continuous regular medication that is deemed not to influence the study outcomes regarding the efficacy of the investigational product will be allowed.
Participants will be required not to modify their diet or physical activity during the course of the study.
The inclusion process will take place during winter months, to ensure that the study coincides with the months of highest URTI incidence.
Since this clinical trial will be conducted in minors, continuous evaluation will be the responsibility of the parents. They will be instructed to complete an online questionnaire daily, which will allow data collection to assess the efficacy and safety variables.
Interventions
- Dietary supplement Probiotic - 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 supplement Placebo
The placebo product is provided in 2g sticks of corn starch and maltodextrin.
Primary outcome measures
- Patients who were diagnosed with at least 1, 2 or 3 URTIs [Time frame: 12 and 16 weeks]
- Number of URTIs per patient [Time frame: 12 and 16 weeks]
- Patients who were diagnosed of common cold and influenza [Time frame: 12 and 16 weeks]
Secondary outcome measures (12)
- Participants who presented URTI complications [Time frame: 12 and 16 weeks]
- Number of days with a URTI episode per participant [Time frame: 12 and 16 weeks]
- Number of days until the first URTI [Time frame: 12 weeks]
- Duration of each URTI episode [Time frame: 12 and 16 weeks]
- URTI-free time rate [Time frame: 12 and 16 weeks]
- Score of each symptom evaluated on the Jackson scale [Time frame: 12 and 16 weeks]
- Number of days with fever per participant [Time frame: 12 and 16 weeks]
- Participants who received antibiotic treatment [Time frame: 12 and 16 weeks]
- Number of days with antibiotic treatment per participant [Time frame: 12 and 16 weeks]
- Proportion of URTI episodes in which participants received symptomatic medication [Time frame: 12 and 16 weeks]
- Proportion of URTI days in which participants received symptomatic medication [Time frame: 12 and 16 weeks]
- Participants who experienced gastrointestinal infections [Time frame: 12 and 16 weeks]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Prevention
Study locations
Spain · 1 center
- MiBioPath Research Group (UCAM) — Murcia
Identifiers
NCT: NCT07154992 · IRESP.PROB-2