Actively Recruiting
Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Efficacy and Safety of Lacticaseibacillus Rhamnosus CRL1505 in Preventing Upper Respiratory Tract Infections in Healthy Children
Led by Bioithas SL · Updated on 2025-09-12
268
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
Sponsors
B
Bioithas SL
Lead Sponsor
C
Centro Sperimentale del Latte S.r.l.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of a probiotic called Lacticaseibacillus rhamnosus CRL1505 on preventing or reducing upper respiratory tract infections (URTIs) in healthy children aged 3 to 12 years. This clinical trial is randomized, double-blind, and placebo-controlled to ensure reliable results. The study focuses on a pediatric population during the winter months when URTIs are most common, aiming to assess both the safety and effectiveness of the probiotic strain in this group. Participants will be randomly assigned to one of two groups: one receiving the probiotic and the other a placebo, both given as 2g sticks with similar appearance. The intervention period lasts 12 weeks, followed by an additional 4-week post-treatment follow-up, totaling 16 weeks. During the study, participants should maintain their usual diet and physical activity without changes. Parents will be responsible for daily monitoring and will complete an online questionnaire to record symptoms, safety, and other health data. Researchers will assess the number and severity of URTI episodes, use of medications, school absences, and other health outcomes at 12 and 16 weeks. This careful tracking helps evaluate how the probiotic may influence URTI prevention and recovery in children.
CONDITIONS
Brief Title
Clinical Trial to Evaluate the Efficacy of Lacticaseibacillus Rhamnosus CRL1505 in the Prevention of Upper Respiratory Tract Infections in Children
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy children aged 3 to 12 years
- Signed informed consent by the parents
You will not qualify if you...
- Chronic diseases such as asthma, chronic bronchitis, heart, neurological, liver, kidney, gastrointestinal diseases, hematological disorders, or other significant health conditions
- Metabolic disorders like diabetes or obesity
- Immunodeficiency including HIV infection or chronic corticosteroid treatment
- Nasal conditions causing obstruction like nasal polyps or ulcers
- Use of medications or dietary supplements affecting study results (immunosuppressants, immunostimulants, analgesics, anti-inflammatories, cough medicines, antibiotics, antihistamines, probiotics) within 4 weeks before study start
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants take the probiotic or placebo daily to help prevent upper respiratory tract infections.
Daily intake with parental monitoring and online questionnaires
Duration - 4 weeks
Participants are monitored for safety and any infections after treatment ends.
Parental monitoring with daily online questionnaires
Trial Site Locations
Total: 1 location
1
MiBioPath Research Group (UCAM)
Murcia, Spain
Actively Recruiting
Research Team
J
Juan Gabriel Agüera Santos
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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