Human Microbiome Research and Development for Overcoming Pediatric Diseases

February 1, 2025 updated by: Hyun-Kyung Park, Hanyang University

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

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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • subjects who did not obtain consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 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
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)
4 months old, 1 year old, 3 years old, school age
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
2 months old, 4 months old, 6 months old, 1 year old, and then every year until the age of ten years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hanyang University

Investigators

  • Principal Investigator: Hyun-Kyung Park, MD, Hanyang University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2022

Primary Completion (Estimated)

January 1, 2026

Study Completion (Estimated)

January 1, 2030

Study Registration Dates

First Submitted

January 2, 2025

First Submitted That Met QC Criteria

February 1, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 1, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • HYUMC IRB No. 2023-04-047

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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