Human Microbiome Research and Development for Overcoming Pediatric Diseases

Recruiting

• Conditions: Human Microbiome; Pediatrics; Disease; Growth & Development

• Registration Number: NCT06812091
• Lead Sponsor: Hanyang University

Brief Summary

Prediction and treatment of pediatric diseases and long-term outcomes through microbiome and multi-omics analysis by life cycle: We aim to demonstrate that a wide range of diseases are associated with gut microbiome dysbiosis and to investigate the subsequent recovery (restoration) or further deterioration of the gut microbiome over time. This study seeks to offer a novel perspective on changes in the gut microbiome, particularly in the context of the gut-lung and gut-brain axes.

Detailed Description

Fecal samples are collected and analyzed from birth through childhood, including those from both preterm and term infants. Based on these collected samples, groups are categorized into disease groups commonly observed in children. Genomic DNA is extracted from the fecal samples, followed by high-throughput 16S rRNA amplicon sequencing to analyze the microbial composition. Additionally, multiomics analyses, including metabolomics, are conducted to provide a comprehensive understanding of gut microbiome dynamics. The impact on the microbiome is further investigated in vitro using a fermenter-based intestinal microbiota model system.

Study Timeline

• Study Start: 2022-01-01
• Study First Submitted: 2025-01-02
• Status Verified: 2025-02
• Study First Submitted QC: 2025-02-01
• Last Update Submitted: 2025-02-01
• Study First Posted: 2025-02-06
• Last Update Posted: 2025-02-06
• Primary Completion: 2026-01-01
• Study Completion: 2030-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• children (including newborns) who have obtained their consent from their guardians

Exclusion Criteria

• subjects who did not obtain consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Follow-up of growth percentile in height, weight, and head circumference	2 months old, 4 months old, 6 months old, 1 year old, and then every year until the age of ten years	Monitoring the baby's growth status compared to the Nomogram growth chart
Obervation of age-specific developmental milestones	4 months old, 1 year old, 3 years old, school age	Judging whether the development status is appropriate according to developmental milestones based on developmental screening tests and doctors' opinions)
Observations on the incidence and frequency of enteritis, sepsis, and respiratory diseases	2 months old, 4 months old, 6 months old, 1 year old, and then every year until the age of ten years	The dysbiosis of the gut microbiome affects various organs, such as the gut-lung axis and the gut-brain axis, in addition to the disease of the intestine itself, so monitor the occurrence of infectious diseases

Trial Locations

Locations (1)

Hanyang University Medical Center; 🇰🇷 Seoul, Korea, Republic of