Evaluation of the Clinical Efficacy of Antrrix Probiotics in Improving Recurrent Respiratory Infections in Infants and Young Children
Min-Tze LIONG
120 participants
May 14, 2025
INTERVENTIONAL
Conditions
Summary
This study is an 8-weeks, randomized controlled trial involving children under 6 years of age who meet clinical diagnostic criteria for RRTI. Participants are randomized to receive either probiotic or placebo. The primary clinical outcomes assessed are duration and frequency of respiratory symptoms and quality of life. To investigate potential mechanisms, stool samples were collected pre- and post-intervention for 16S rRNA gene sequencing to analyze changes in gut microbiota composition and identify specific bacterial taxa associated with clinical improvements.
Eligibility
Inclusion Criteria5
- Age \< 6 years, gender not limited;
- Meets the clinical diagnostic criteria for recurrent respiratory tract infections (Clinical Diagnosis and Treatment Pathway for Recurrent Respiratory Tract Infections in Children (2022 Edition) 10 );
- Parents or other legal guardians of the child fully understand the trial and voluntarily sign informed consent forms before the start of any research procedure;
- Willing to discontinue the use of other probiotics during the trial;
- Agree to the collection of fecal biological samples during this trial.
Exclusion Criteria6
- Those deemed by the investigator to have poor compliance or be unsuitable for participation;
- Allergic to the investigational product and its components;
- Allergic to respiratory tract infection drugs and their components;
- Respiratory infections caused by underlying diseases such as primary immunodeficiency diseases, acquired immunodeficiency syndrome (ADRS), congenital airway malformations, congenital heart disease, gastroesophageal reflux disease (GERD), and pulmonary dysplasia;
- Patients with severe malnutrition, rickets, and severe primary diseases of the heart, brain, liver, kidney, and hematopoietic systems;
- Use probiotic preparations, antibiotics, immunostimulants, or immunosuppressants 4 weeks before participating in the experiment.
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Interventions
Daily 2 × 10 9 CFU per 6 drops containing Lactobacillus rhamnosus CRL1505+Bifidobacterium brevis M-16V strain in MCT oil
Daily 6 drops MCT oil without probiotics
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07297966