About this trial
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 metagenomics gene sequencing to analyze changes in gut microbiota composition and identify specific bacterial taxa associated with clinical improvements.
Eligibility criteria
Qualifiers
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;
Disqualifiers
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;
Trial design
Treatments tested in this trial
- Probiotic
- Placebo
Treatment groups
Sponsors and collaborators
Min-Tze LIONG
Lead sponsor
Universiti Sains Malaysia
Sponsor institution
Xinyi City People's Hospital
Collaborator