Antrrix probiotics to reduce recurrent respiratory infections in young children

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.