An observational study in Human Microbiome, Pediatrics and Disease, sponsored by Hanyang University. Recruiting at 1 site in Korea, Republic of. Per ClinicalTrials.gov, last updated 2025-02-06.
Sponsored by Hanyang University · Observational
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.
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.
Hanyang University is the lead sponsor of 52 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Follow-up of growth percentile in height, weight, and head circumference
Monitoring the baby's growth status compared to the Nomogram growth chart
Time frame: 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)
Time frame: 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
Time frame: 2 months old, 4 months old, 6 months old, 1 year old, and then every year until the age of ten years
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Hanyang University