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临床试验/NCT02699320
NCT02699320已完成不适用

Multi-center Clinical Research About Standard Diagnosis and Treatment of Neonate Severe Digestive System Malformation

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine1 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2015年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
33
试验地点
1
主要终点
Microbial structure in SBS infants

研究概览

简要总结

There are no reports involved the intestinal microbiota from Chinese infants with short bowel syndrome (SBS) under different clinical status. Alterations in the microbiota are closely correlated with the bile acids and short chain fatty acids metabolism as well as the intestinal immunity. A relatively comprehensive profile composed of microbial structure, microbial metabolism products and immune biomarkers in SBS infants may facilitate a better therapy strategy to complications occurred in SBS children.

详细描述

The investigators totally collected 26 fecal samples from 18 infants diagnosed with SBS during parenteral nutrition administration, and these samples were divided into three groups according to complications of enrolled patients at sampling time: asymptomatic group, central catheter-related blood stream infections group and liver injury group. 7 healthy infants with supplementary food were enrolled as control. Fecal microbiota, sIgA and calprotectin, bile acids and short chain fatty acids were also detected by 16S ribosomal ribonucleic acid (rRNA) gene sequencing, enzyme-linked immunosorbent assay and liquid/gas chromatography.

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
— 至 1 Year(Child)
性别
All
接受健康志愿者

入选标准

  • Infants with short bowel syndrome

排除标准

  • 未提供

结局指标

主要结局

Microbial structure in SBS infants

时间窗: up to 4 months

Fecal microbiota were detected by 16S rRNA gene sequencing.

次要结局

  • Metabolism products in SBS infants(up to 4 months)
  • Immune biomarkers in SBS infants(up to 4 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jiang WU

MD.

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

研究点 (1)

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