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Human Microbiome Research and Development for Overcoming Pediatric Diseases

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06812091
Enrollment
500
Registered
2025-02-06
Start date
2022-01-01
Completion date
2030-01-01
Last updated
2025-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Disease, Growth & Development, Human Microbiome, Pediatrics

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.

Interventions

None listed

Sponsors

Hanyang University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

* subjects who did not obtain consent

Design outcomes

Primary

MeasureTime frameDescription
Follow-up of growth percentile in height, weight, and head circumference2 months old, 4 months old, 6 months old, 1 year old, and then every year until the age of ten yearsMonitoring the baby's growth status compared to the Nomogram growth chart
Obervation of age-specific developmental milestones4 months old, 1 year old, 3 years old, school ageJudging 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 diseases2 months old, 4 months old, 6 months old, 1 year old, and then every year until the age of ten yearsThe 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

Countries

South Korea

Contacts

Primary ContactHyun-Kyung Park, MD
neopark@hanyang.ac.kr82-10-4749-1454

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026