Human Microbiome Research and Development for Overcoming Pediatric Diseases

NCT06812091 | Recruiting DMC

• 1 other identifier: HYUMC IRB No. 2023-04-047
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Human Microbiome; Pediatrics; Disease; Growth & Development

Outcome Measures

Primary Outcomes (3)

• Follow-up of growth percentile in height, weight, and head circumference

  Monitoring the baby's growth status compared to the Nomogram growth chart

  2 months old, 4 months old, 6 months old, 1 year old, and then every year until the age of ten years

• Obervation of age-specific developmental milestones

  Judging whether the development status is appropriate according to developmental milestones based on developmental screening tests and doctors' opinions)

  4 months old, 1 year old, 3 years old, school age

• Observations on the incidence and frequency of enteritis, sepsis, and respiratory diseases

  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

  2 months old, 4 months old, 6 months old, 1 year old, and then every year until the age of ten years

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Control group: healthy infants without any diagnosed diseases, born full-term, exhibiting normal growth and development. Case group: infants with diagnosed diseases, including those born prematurely, those with a history of neonatal intensive care unit (NICU) admission, and those exhibiting neurodevelopmental impairments.

You may qualify if:

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

You may not qualify if:

• subjects who did not obtain consent

Sponsors & Collaborators

• Hanyang University: lead

Study Sites (1)

Hanyang University Medical Center

Seoul, 04763, South Korea

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

fecal DNA extraction and storage for NGS analysis

MeSH Terms

Conditions

Disease

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Hyun-Kyung Park, MD

  Hanyang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hyun-Kyung Park, MD

CONTACT

82-10-4749-1454; neopark@hanyang.ac.kr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, MD, PhD

Study Record Dates

• First Submitted: January 2, 2025
• First Posted: February 6, 2025
• Study Start: January 1, 2022
• Primary Completion: January 1, 2026
• Study Completion (Estimated): January 1, 2030
• Last Updated: February 6, 2025

Record last verified: 2025-02

Locations

KR (1)