Lacticaseibacillus rhamnosus probiotic to prevent upper respiratory infections in children

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

This will test whether a daily Lacticaseibacillus rhamnosus CRL1505 probiotic can prevent or reduce colds in healthy children aged 3–12.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 268 (estimated)
• Ages: 3 Years to 12 Years
• Sex: All
• Sponsor: Bioithas SL (industry)
• Locations: 1 site (Murcia)
• Trial ID: NCT07154992 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Healthy children aged 3 to 12 years whose parents can provide informed consent and who can attend scheduled visits are ideal candidates.

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.

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 performed: 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.

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.

Where this trial is running

Murcia

• MiBioPath Research Group (UCAM) — Murcia, Spain (RECRUITING)

Study contacts

• Study coordinator: Juan Gabriel Agüera Santos

Conditions: Upper Respiratory Tract Infection, Prevention, prevention, upper respiratory tract infections, probiotics, microbiota, microbiome, children