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RECRUITING
NCT07297966
PHASE2

Evaluation of the Clinical Efficacy of Antrrix Probiotics in Improving Recurrent Respiratory Infections in Infants and Young Children

Sponsor: Min-Tze LIONG

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

1 Day - 6 Years

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2025-05-14

Completion Date

2026-01-31

Last Updated

2025-12-30

Healthy Volunteers

No

Interventions

DIETARY_SUPPLEMENT

Probiotic

Daily 2 × 10 9 CFU per 6 drops containing Lactobacillus rhamnosus CRL1505+Bifidobacterium brevis M-16V strain in MCT oil

DIETARY_SUPPLEMENT

Placebo

Daily 6 drops MCT oil without probiotics

Locations (2)

Xinyi City People's Hospital

Xingyi, Guangdong, China

Universiti Sains Malaysia

George Town, Pulau Pinang, Malaysia