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Effects of Probiotics on Respiratory Tract Infections in Children: A Randomized, Placebo-Controlled Interventional Study
Sponsor: Min-Tze LIONG
Summary
This study is a 14-day, randomized, double-blind, placebo-controlled trial involving children aged 3 months to 6 years who meet clinical diagnostic criteria for mild to moderate upper respiratory tract infection (URTI). Participants are randomized to receive either a mixed probiotic preparation (Lactobacillus rhamnosus CRL1505 and Bifidobacterium breve M-16V) or a placebo. The primary clinical outcome assessed is the duration and severity of respiratory symptoms. Secondary outcomes include changes in gut microbiota composition, intestinal immune markers, and quality of life. To investigate potential mechanisms, fecal samples are collected before and after intervention for metagenomic sequencing to analyze microbial diversity and composition, alongside immunological assessments such as sIgA and calprotectin.
Key Details
Gender
All
Age Range
3 Months - 6 Years
Study Type
INTERVENTIONAL
Enrollment
120
Start Date
2026-02-01
Completion Date
2026-12-31
Last Updated
2026-04-02
Healthy Volunteers
No
Conditions
Interventions
Probiotic
Daily 6-drops of 1 × 10\^10 CFU containing Lactobacillus rhamnosus CRL1505 and Bifidobacterium breve M-16V in MCT oil
Placebo Control
Daily 6-drops of MCT oil containing non-GMO corn starch
Locations (2)
Shanghai Sixth People's Hospital
Xuhui, Shanghai Municipality, China
Universiti Sains Malaysia
Pulau Pinang, Pulau Pinang, Malaysia