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

NCT07297966 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2026-04-17

No results posted yet for this study

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 metagenomics gene sequencing to analyze changes in gut microbiota composition and identify specific bacterial taxa associated with clinical improvements.

Conditions

  • Recurrent Respiratory Tract Infections

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

Sponsors & Collaborators

  • Xinyi City People's Hospital

    collaborator UNKNOWN

  • Min-Tze LIONG

    lead OTHER

Principal Investigators

  • Sitao Li, MD. · The Sixth Affiliated Hospital of Sun Yat-sen University, Xinyi People's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-14
Primary Completion
2026-06-30
Completion
2026-06-30

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 NCT07297966 on ClinicalTrials.gov