Prediction and Treatment of Pediatric Diseases and Long-term Outcomes Through Microbiome and Multi-Omics Study by Life Cycle
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Follow-up of growth percentile in height, weight, and head circumference
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •children (including newborns) who have obtained their consent from their guardians
排除标准
- •subjects who did not obtain consent
结局指标
主要结局
Follow-up of growth percentile in height, weight, and head circumference
时间窗: 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
Obervation of age-specific developmental milestones
时间窗: 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)
Observations on the incidence and frequency of enteritis, sepsis, and respiratory diseases
时间窗: 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
次要结局
未报告次要终点
研究者
Hyun-Kyung Park
Professor, MD, PhD
Hanyang University