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.
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.
Study Type
INTERVENTIONAL
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.
The placebo product is provided in 2g sticks of corn starch and maltodextrin.
MiBioPath Research Group (UCAM)
Murcia, Spain
RECRUITINGPatients 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
Time frame: 12 and 16 weeks
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)
Time frame: 12 and 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.
Time frame: 12 and 16 weeks
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.
Time frame: 12 and 16 weeks
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.
Time frame: 12 and 16 weeks
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.
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Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
268
Time frame: 12 weeks
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.
Time frame: 12 and 16 weeks
URTI-free time rate
Difference in the URTI-free time rate (proportion of accumulated days in which participants do not experience URTI relative to the total number of days) during the intervention period (12 weeks) and the total follow-up period (16 weeks) between the study groups.
Time frame: 12 and 16 weeks
Score of each symptom evaluated on the Jackson scale
Difference in the average score of each symptom evaluated on the Jackson scale per day of common cold episode during the intervention period (12 weeks) and the total follow-up period (16 weeks) between the study groups. The Jackson scale (also known as Jackson criteria or Jackson score) is a tool used to assess and quantify the symptoms of upper respiratory tract infections (URTI), such as the common cold It evaluates 8 main symptoms: Sneezing, Nasal discharge (runny nose), Nasal congestion, Sore throat, Cough, Headache, Malaise, Chilliness/feverishness Each symptom is scored on a 0-3 scale: 0 = absent 1. = mild 2. = moderate 3. = severe Criteria for defining a "cold episode" (URTI case) according to Jackson: At least 2 consecutive days with ≥2 of the following symptoms: runny nose, sore throat, sneezing. Or 1 of these symptoms plus at least one systemic symptom (headache, malaise, chilliness/feverishness).
Time frame: 12 and 16 weeks
Number of days with fever per participant
Difference in the average number of days with fever per participant during the intervention period (12 weeks) and the total follow-up period (16 weeks) between the study groups.
Time frame: 12 and 16 weeks
Participants who received antibiotic treatment
Difference in the proportion of participants who received antibiotic treatment during the intervention period (12 weeks) and the total follow-up period (16 weeks) between the study groups.
Time frame: 12 and 16 weeks
Number of days with antibiotic treatment per participant
Difference in the average number of days with antibiotic treatment per participant during the intervention period (12 weeks) and the total follow-up period (16 weeks) between the study groups.
Time frame: 12 and 16 weeks
Proportion of URTI episodes in which participants received symptomatic medication
Difference in the proportion of URTI episodes in which participants received symptomatic medication (to relieve URTI symptoms) during the intervention period (12 weeks) and the total follow-up period (16 weeks) between the study groups.
Time frame: 12 and 16 weeks
Proportion of URTI days in which participants received symptomatic medication
Difference in the proportion of URTI days in which participants received symptomatic medication (to relieve URTI symptoms) during the intervention period (12 weeks) and the total follow-up period (16 weeks) between the study groups.
Time frame: 12 and 16 weeks
Participants who experienced gastrointestinal infections
Difference in the proportion of participants who experienced gastrointestinal infections during the intervention period (12 weeks) and the total follow-up period (16 weeks) between the study groups.
Time frame: 12 and 16 weeks
School absence rate
Difference in the school absence rate (proportion of accumulated school absence days due to URTI relative to the total number of days) during the intervention period (12 weeks) and the total follow-up period (16 weeks) between the study groups.
Time frame: 12 and 16 weeks