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临床试验/NCT03102281
NCT03102281Unknown不适用

Gastrointestinal Microbiomes in Patients of Recurrent Common Bile Duct Stones After Endoscopic Sphincterotomy(EST)

The Second Hospital of Nanjing Medical University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2017年5月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
100
试验地点
1
主要终点
Changes of Bacteria in Body Fluid

研究概览

简要总结

Bile duct stones is a common biliary tract disease, which is characterized by high morbidity and frequent recurrence. Endoscopic retrograde cholangiopancreatography (ERCP) is an effective therapy for common bile duct stones, and endoscopic sphincterotomy (EST) which associated with recurrent cholangiolithiasis often carried out on difficult intubation or extracting stones, probably due to enhanced reflux of intestinal contents that changes the microenvironment. Patients with cholangiolithiasis were consecutively recruited and their bile was collected intra-operatively for high-throughput experiments. Pyrosequencing of 16S ribosomal RNA gene was performed to characterize the microbiota in the bile and other body fluids. A liquid chromatography mass spectrometry-based method was used to profile bile composition. Clinical manifestation, microbiome, and bile composition were compared between patients with or without recurrent of bile duct stones. The aim of our study was to identify the impact of microbiomes on the recurrent of bile duct stones after ERCP+EST therapy.

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
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with recurrent common bile duct stones.
  • No antibiotics or probiotics are used for nearly three months.
  • In addition to common bile duct stones, possibly without other digestive diseases.

排除标准

  • Significant neurological or psychiatric disorders (psychotic disorders, dementia or seizures) that would prohibit the understanding and giving of informed consent.
  • Pregnant or lactating females.
  • Active Hepatitis B or C or history of an HIV infection.
  • Active uncontrolled infection.
  • Billroth II or roux-en Y gastrointestinal alteration people.

结局指标

主要结局

Changes of Bacteria in Body Fluid

时间窗: 3 years

measure the changes of Bacteria in Body Fluid

次要结局

  • Stone diameter(3 years)
  • Bile acid composition(Mass spectrometry or Chromatography)(3 years)
  • EST size(3 years)
  • Stone type(3 years)

研究者

发起方
The Second Hospital of Nanjing Medical University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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