Fecal Microbium Change in Pediatric Patients With Spina Bifida: Prospective Case-control Study
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- the alpha or beta diversity of intestinal microbiota composition in children with spina bifida is different from that of normal control
研究概览
简要总结
Purpose: In order to verify the hypothesis that the composition of intestinal microbiota in children with spina bifida is different from that of normal control, prospective comparative analysis would be performed.
Background of the study:
Spina bifida is a congenital neurological disorder, causing neurogenic bowel. It has been known that the intestinal microbiota in spinal cord injury patient was different than that of control. Changes in intestinal motility, mucous secretion, immune surveillance, and epithelial barrier permeability are possible causes of this change. As spina bifida is also related with neurogenic bowel, the investigators hypothesized that the intestinal microbiota in spina bifida is different from that of normal control.
Patients total 30 patients and 10 controls Inclusion for patients
Patients who meet following conditions:
-
Children over 3 years old and under 12 years old who have been diagnosed with spinal bifida with spinal MRI Exclusion for patients and controls
-
Children with known inflammatory bowel disease or cloacal anomaly
Statistical analysis Statistical processing for fecal samples is aimed at alpha or beta diversity using bioinformatics, and the Kruskal-Wallis test is used to compare similarities or differences between each fecal sample. Prior to statistical analysis, the relative abundance of the detected microorganisms is analyzed first, and microorganisms having a distribution less than 0.1% are excluded from the analysis, and the remaining microorganisms are analyzed in the 'genus' step.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 3 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children aged 3-12 years, diagnosed with spina bifida in spinal MRI.
排除标准
- •The patient has an inflammatory intestinal disease known in the colon or has a cloacal anomaly.
结局指标
主要结局
the alpha or beta diversity of intestinal microbiota composition in children with spina bifida is different from that of normal control
时间窗: 1 year
Feces are collected about 1-2 grams and stored at -80'c refrigerator. After analysis, using biometrics, statistical processing for fecal samples is aimed at alpha or beta diversity. The Kruskal-Wallis test is used to compare similarities or differences between each fecal sample. Prior to statistical analysis, the relative abundance of the detected microorganisms is analyzed first, and microorganisms having a distribution less than 0.1% are excluded from the analysis, and the remaining microorganisms are analyzed in the 'genus' step.
次要结局
未报告次要终点