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ENROLLING BY INVITATION
NCT07498127
PHASE2

Effects of Probiotics on Respiratory Tract Infections in Children: A Randomized, Placebo-Controlled Interventional Study

Sponsor: Min-Tze LIONG

View on ClinicalTrials.gov

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

DIETARY_SUPPLEMENT

Probiotic

Daily 6-drops of 1 × 10\^10 CFU containing Lactobacillus rhamnosus CRL1505 and Bifidobacterium breve M-16V in MCT oil

DIETARY_SUPPLEMENT

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