Study of Normal Intestinal Development and Disease in Premature and Term Neonates - a Pathway for the Study of Premature and Neonatal Intestinal Disorders Including the Roles of Nutrition, Microbes, and Cellular Physiology, and Diseases Including Necrotizing Enterocolitis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 主要终点
- Number of intestinal stem cells and mature epithelial cells
研究概览
简要总结
Current research on early intestinal development is primarily performed in mouse models. While useful in many other ways, mouse models are not ideal for studying human intestine development as the timing of this process differs between the two species. Further, prior research has demonstrated that some proteins and pathways that are critical in human development have no clear role in mice.
This study aims to improve the overall understanding of critical aspects of intestinal development in humans. In addition, this study will investigate the impact of intestinal diseases that are found in the early stages of life such as necrotizing enterocolitis (NEC).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 2 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any neonate or infant through 2 years of age having intestinal surgery or intestinal biopsies from an esophogastroduodenoscopy (EGD) or colonoscopy.
排除标准
- •Children > 2 years of age.
- •Infants 0-2 years old not undergoing GI surgery or intestinal scope with biopsy procedure.
结局指标
主要结局
Number of intestinal stem cells and mature epithelial cells
时间窗: At the time of surgery for another clinical problem.
Small intestinal biopsy specimens will be collected either from discarded surgical biopsies collected for clinical reasons or from 1-2 additional small bunch biopsies (5mm) near the surgery site. The tissue will be used to 1.) generate organoids for longitudinal cell culture, 2.) analyze RNA or protein components by transcriptomic or cellular analyses or 3.) analyze histology. We do not have discrete planned outcomes because this is an investigational study and we are looking for new trends or differences.
Degree of Immune System Changes
时间窗: Within 48 hours before or after the clinically-driven surgery.
We will collect a small 1 tsp amount of blood (5mL) and use this to analyze immune cell types or cytokines in the blood. These will include monocytes, T cell, B cells, and neutrophils for the cell types. Cytokines will include IL-1, IL-2, IL-3, IL-4, Il-5, IL-6, Il-8, IL10, IL-13, IL-22, IL-33, TNFa, IFNg, IFNa, MCP1, MIP1a.
Fraction of Stool Microbiome that has beneficial microbes
时间窗: Within 48 hours before or after the surgery from which the biopsy is obtained.
We will collect stool samples to analyze the microbiome using bulk microbial RNA sequencing.
次要结局
未报告次要终点
研究者
Amy O'Connell
Physician in Medicine, Division of Newborn Medicine; Director of Infection Control, Neonatal ICU; Faculty, Neonatal Genomics Program
Boston Children's Hospital