Human Microbiome Research and Development for Overcoming Pediatric Diseases

NCT ID: NCT06812091

Last Updated: 2025-02-06

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-01-01
• Study Completion Date: 2030-01-01

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.

Conditions

Human Microbiome; Pediatrics; Disease; Growth & Development

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• subjects who did not obtain consent

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hanyang University

OTHER

Sponsor Role: lead

Responsible Party

Hyun-Kyung Park

Professor, MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hyun-Kyung Park, MD

Role: PRINCIPAL_INVESTIGATOR

Hanyang University

Locations

Hanyang University Medical Center

Seoul, , South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Hyun-Kyung Park, MD

Role: CONTACT

neopark@hanyang.ac.kr

82-10-4749-1454

Facility Contacts

Hyun-Kyung Park, MD

Role: primary

neopark@hanyang.ac.kr

82-10-4749-1454

Other Identifiers

HYUMC IRB No. 2023-04-047

Identifier Type: -

Identifier Source: org_study_id