Actively Recruiting
Evaluation of the Clinical Efficacy of Antrrix Probiotics in Improving Recurrent Respiratory Infections in Infants and Young Children
Led by Min-Tze LIONG · Updated on 2026-04-17
120
Participants Needed
2
Research Sites
58 weeks
Total Duration
On this page
Sponsors
M
Min-Tze LIONG
Lead Sponsor
X
Xinyi City People's Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Evaluation of the Clinical Efficacy of Antrrix Probiotics in Improving Recurrent Respiratory Infections in Infants and Young Children
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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.
You will not qualify if you...
- 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.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Xinyi City People's Hospital
Xingyi, Guangdong, China
Actively Recruiting
2
Universiti Sains Malaysia
George Town, Pulau Pinang, Malaysia, 11800
Not Yet Recruiting
Research Team
M
Min-Tze Liong, Ph.D.
CONTACT
J
Jie Yuan, M.Sc.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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