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NCT Number: NCT06812091

Human Microbiome Research and Development for Overcoming Pediatric Diseases

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.

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Key information

Conditions

Human Microbiome Disease Growth & Development Pathologic Processes Pathological Conditions, Signs and Symptoms Pediatrics

Sex eligibility

All sexes

Study type

Observational

Primary location

Hanyang University Medical Center

Seoul, 04763, South Korea

Location status: Recruiting

Location contact

Hyun-Kyung Park, MD

CONTACT

[email protected]

82-10-4749-1454

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • subjects who did not obtain consent

Treatment and study plan

Primary outcomes

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

    Time frame: 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

  2. Obervation of age-specific developmental milestones

    Time frame: 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)

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

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Hyun-Kyung Park, MD

CONTACT

[email protected]

82-10-4749-1454

Sponsors and collaborators

Lead sponsor

Hanyang University

Other

Registry information

Official study title

Prediction and Treatment of Pediatric Diseases and Long-term Outcomes Through Microbiome and Multi-Omics Study by Life Cycle

Important dates

Study start
2022
Primary completion
2026
Study completion
2030
First posted
Feb 6, 2025
Registry last updated
Feb 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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