The Role and Mechanism of Intestinal Dysbacteriosis Impairing the Intestinal Mucosal Barrier in the Pathogenesis of Necrotizing Enterocolitis in Premature Infants
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- short-chain fatty acids
研究概览
简要总结
Study Description
The goal of this observational study is to detect intestinal flora and the metabolic products in premature infants diagnosed as necrotizing enterocolitis. The main questions it aims to answer are:
-
- Whether there is intestinal flora in the stool of premature infants.
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- Are there dysregulated intestinal flora and their metabolic products in premature infants diagnosed as necrotizing enterocolitis.
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- The detailed role and underlying mechanism of the intestinal dysbacteriosis and the metabolic products in premature infants diagnosed as necrotizing enterocolitis.
Participants, premature infants diagnosed as necrotizing enterocolitis (NEC group), will be asked to collect stool (usually 2 times) for intestinal flora analysis.
If there is a comparison group: Researchers will compare premature infants without necrotizing enterocolitis (control group) to see if their intestinal flora and the metabolic products also changed as their NEC counterparts.
详细描述
When the patients is hospitalized in neonatology, we screen the premature infants according to the selection criteria and exclusion criteria. After sighed the informed consent, they are classified into two groups: premature infants diagnosed as necrotizing enterocolitis (NEC group) and premature infants without necrotizing enterocolitis (control group). Their stool and blood (usually 2 times ) are collected for intestinal flora and FABP (including L-FABP and I-FABP) analysis, respectively.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 5 Days 至 2 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •clinical diagnosis of Necrotizing Enterocolitis,
- •gestational age <37 weeks,
- •body weight 1,000-2,500 g,
- •postnatal Apgar score ≥7,
- •initial oral feeding tolerance.
排除标准
- •serious hereditary or other serious diseases, such as heart, lung and abdominal malformations ,
- •early or late onset septicemia,
- •early use of antibiotics in the newborn,
- •serious adverse reactions caused by probiotics.
结局指标
主要结局
short-chain fatty acids
时间窗: up to 4 weeks
short-chain fatty acids, the metabolic products of intestinal flora, in the stool using 16S rRNA gene sequencing
L-FABP
时间窗: up to 4 weeks
L-FABP, the injury marker of intestinal mucosa, in the blood
I-FABP
时间窗: up to 4 weeks
I-FABP, the injury marker of intestinal mucosa, in the blood
hospital stay
时间窗: up to 4 weeks
one vital clinical outcome of the premature infants
intestinal flora
时间窗: up to 4 weeks
the intestinal flora in the stool using 16S ribosomal RNA(rRNA) gene sequencing
lipopolysaccharide
时间窗: up to 4 weeks
lipopolysaccharide, a metabolic product of intestinal flora, in the stool using 16S rRNA gene sequencing
neurotransmitters
时间窗: up to 4 weeks
neurotransmitters, the metabolic products of intestinal flora, in the stool using 16S rRNA gene sequencing
次要结局
- procalcitonin(up to 4 weeks)
- X-ray(up to 4 weeks)
- c-reactive protein(up to 4 weeks)
- complete blood count(up to 4 weeks)
研究者
Zuohui Zhao
Associate professor
Qianfoshan Hospital