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ID06812091

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

Led by Hanyang University · Updated on 2025-02-06

500

Participants Needed

1

Research Sites

208 weeks

Total Duration

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AI-Summary

What this Trial Is About

Researchers are studying how changes in the gut microbiome relate to a variety of pediatric diseases and long-term health outcomes. This observational study focuses on understanding the connection between gut microbiome imbalances and diseases in children, while exploring how the microbiome recovers or worsens over time. The study aims to provide new insights into the gut-lung and gut-brain interactions during childhood. Fecal samples are collected regularly from newborns, including both preterm and full-term infants, through childhood. These samples undergo detailed analysis using genomic DNA extraction and 16S rRNA sequencing to identify microbial composition. Multiomics approaches, such as metabolomics, further explore gut microbiome dynamics. Laboratory models simulate the intestinal environment to study the microbiome's impact. Participants are followed from birth up to ten years old with regular monitoring of growth measures like height, weight, and head circumference at multiple timepoints. Developmental milestones are also tracked at key ages. The study observes the occurrence and frequency of infections such as enteritis, sepsis, and respiratory diseases. This long-term follow-up helps researchers understand microbiome changes and their health implications over childhood.

CONDITIONS

Brief Title

Human Microbiome Research and Development for Overcoming Pediatric Diseases

Who Can Participate

All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Children (including newborns) who have obtained consent from their guardians
Not Eligible

You will not qualify if you...

  • Subjects who did not obtain consent from their guardians to participate in the study or sample collection process or for using the data obtained from samples in the study analysis and publication of results. This applies to any reason for withholding consent or refusal to continue participation in the study after enrollment or any reason to discontinue participation in the study after enrollment due to the inability to continue participation or withdrawal of consent during the study process or any other reason related to the study procedure or participation in the study, including the follow-up period. This also applies when a study participant is deceased during the study period and the consent from the guardian is not obtained for the use of the data and/or samples collected thus far during the study process.

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Monitoring

Duration - From birth up to 10 years

Participants are observed with fecal sample collection and developmental assessments from birth through childhood to study growth, disease incidence, and microbiome changes.

Visits at 2 months, 4 months, 6 months, 1 year, and annually until age 10

Trial Site Locations

Total: 1 location

1

Hanyang University Medical Center

Seoul, South Korea, 04763

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Research Team

H

Hyun-Kyung Park, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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