Antrrix probiotics to reduce recurrent respiratory infections in young children
Evaluation of the Clinical Efficacy of Antrrix Probiotics in Improving Recurrent Respiratory Infections in Infants and Young Children
Over 8 weeks this trial will see if daily Antrrix probiotic helps children under six have fewer and shorter recurrent respiratory infections and better quality of life.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 1 Day to 6 Years |
| Sex | All |
| Sponsor | Universiti Sains Malaysia Academic / other |
| Locations | 2 sites (Xingyi, Guangdong and 1 other locations) |
| Trial ID | NCT07297966 on ClinicalTrials.gov |
What this trial studies
This is an 8-week, randomized, placebo-controlled Phase 2 trial in children under 6 years old who meet clinical criteria for recurrent respiratory tract infections (RRTI). Participants are randomized to receive either Antrrix probiotic or a matching placebo while clinical outcomes including frequency and duration of respiratory symptoms and quality of life are recorded. Stool samples are collected before and after the intervention for metagenomic sequencing to analyze changes in gut microbiota and to explore bacterial taxa linked to clinical response. The trial is conducted at sites in China and Malaysia and aims to link clinical effects to microbiome shifts.
Who should consider this trial
Good fit: Children younger than 6 years who meet the clinical diagnostic criteria for recurrent respiratory tract infections, whose guardians can give informed consent, agree to stop other probiotics, and permit stool sample collection are ideal candidates.
Not a fit: Children with underlying conditions such as primary immunodeficiency, congenital airway malformations, known allergy to the product, or those deemed unsuitable by investigators are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, the probiotic could reduce how often and how long children experience respiratory infections and improve their day-to-day quality of life.
How similar studies have performed: Prior trials of specific probiotic strains in children have shown mixed but sometimes modest reductions in respiratory infection frequency or severity, making this approach promising but not uniformly proven.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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.
Where this trial is running
Xingyi, Guangdong and 1 other locations
- Xinyi City People's Hospital — Xingyi, Guangdong, China (Recruiting)
- Universiti Sains Malaysia — George Town, Pulau Pinang, Malaysia (Not_yet_recruiting)
Study contacts
- Principal investigator: Sitao Li, MD. — The Sixth Affiliated Hospital of Sun Yat-sen University, Xinyi People's Hospital
- Study coordinator: Min-Tze Liong, Ph.D.
- Email: mintze.liong@usm.my
- Phone: 6046532114
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.