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

NCT07498127 · Status: ENROLLING_BY_INVITATION · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2026-04-02

No results posted yet for this study

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.

Conditions

  • URTI

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

Sponsors & Collaborators

  • Shanghai 6th People's Hospital

    collaborator OTHER

  • Min-Tze LIONG

    lead OTHER

Principal Investigators

  • Jinping Zhang, MD · Shanghai 6th People's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
3 Months
Max Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-01
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • China
  • Malaysia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07498127 on ClinicalTrials.gov