Lacticaseibacillus rhamnosus probiotic to prevent upper respiratory infections in children
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
Run by Bioithas SL · NCT07154992 · Data updated 2026-11-12
This will test whether a daily Lacticaseibacillus rhamnosus CRL1505 probiotic can prevent or reduce colds in healthy children aged 3–12.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 3 Years to 12 Years |
| Sex | All |
| Enrollment | 268 (estimated) |
| Sponsor | Bioithas SL Industry-sponsored |
| Locations | 1 site (Murcia) |
| Status | Recruiting |
| Started | December 17, 2024 |
| Main results expected | March 2027 |
| Study ends | April 2027 |
| Registry record updated | September 12, 2025 |
| Trial ID | NCT07154992 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Healthy children aged 3 to 12 years whose parents can provide informed consent and who can attend scheduled visits are ideal candidates.
✕Probably not a fit
Children with chronic respiratory, immune, metabolic, or other significant illnesses, those on continuous immunomodulating medications, or recent users of similar supplements are unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a randomized, double-blind, placebo-controlled trial that will enroll 268 healthy children aged 3–12 and randomize them 1:1 to receive either Lacticaseibacillus rhamnosus CRL1505 or a matching placebo. The intervention period is 12 weeks with an additional 4-week follow-up to track any new upper respiratory tract infection (URTI) episodes. Outcomes include number of URTI episodes, and measures of episode severity, duration, and safety. Children with chronic illnesses, immunodeficiency, or recent use of medications or supplements that could affect results are excluded.
Why it matters
Potential benefit: If effective, the probiotic could reduce how often children get colds and shorten the length and severity of episodes.
How similar studies have gone: Some prior trials of related L. rhamnosus strains and other probiotics in children have shown modest reductions in URTI incidence or duration, but benefits are strain-specific and results are not uniformly consistent.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
MiBioPath Research Group (UCAM)
Murcia, Spain Recruiting
Study contacts
- Study coordinator: Juan Gabriel Agüera Santos
- Email: juan.aguera@bioithas.com
- Phone: +34623022586
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.