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临床试验/NCT02542579
NCT02542579已完成不适用

Composition of Gastric and Duodenal Microbiota in Dyspeptic Subjects

Konkuk University Medical Center1 个研究点 分布在 1 个国家目标入组 98 人开始时间: 2016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
98
试验地点
1
主要终点
Next generation sequencing analysis for microbiota

研究概览

简要总结

The composition of gastric microbiota is determined by the status of Helicobacter pylori infection. In subjects who have never been infected by H. pylori, gastric microbiota includes various bacteria, creating ideal microbial diversity. This ideal microbial diversity is destroyed by H. pylori infection at low intragastric pH. Since it is difficult for most bacteria to proliferate within an acidic stomach, relative H. pylori abundance gives rise to microbial dysbiosis. Conversely, unideal microbial diversity is often observed in infected individuals with impaired gastric secretory ability at hypochlorhydric condition. Bacteria producing carcinogenic N-nitrosamine compounds are often detected in individuals with past or chronic H. pylori infection at high intragastric pH. Nonetheless, microbial imbalance that occurs in the earlier phase before gastric carcinognenesis is uncertain.

详细描述

Dominant colonization of a specific microbiota leading to dysbiosis may lead to inflammation of the mucosa. We hypothesized that the degree of inflammation depend on the composition of microbiota. This study was aimed to define gastric and duodenal microbiota leading to abnormal histopathology. We further tried to elucidate whether the composition of duodenal microbiota is altered by gastric microbiota.

Among the dyspeptic subjects who visited for upper gastrointestinal (UGI) endoscopy, subjects with drug intake (antibiotics, PPIs, laxatives, antidepressants, statins, metformin) within 3 months will be excluded. Three biopsies will performed at the greater curvature side of the mid-antrum, greater curvature side of the mid-body, and at the duodenum, respectively. Next generation sequencing analysis will be performed for 16S rRNA variable regions using the biopsied samples.

Primary study endpoint is 16S rRNA sequencing findings of gastric and duodenal microbiota.

Secondary endpoints are microbiota linked with higher degrees of inflammation, activity, atrophy and intestinal metaplasia based on the updated Sydney classification. Furthermore, correlation between the microbiota and endoscopy finding will be analyzed.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Dyspeptic subjects who visited for evaluation including upper gastrointestinal endoscopy and biopsies
  • Age >20 years old

排除标准

  • Underlying disease(s) that requires managements
  • Recent intake of drug(s)
  • History of gastrectomy

结局指标

主要结局

Next generation sequencing analysis for microbiota

时间窗: up to 6 months

16S rRNA pyrosequencing analysis findings of the gastric and duodenal biopsies

次要结局

  • Updated Sydney classification(up to 6 months)
  • Gastrointestinal symptom and food intake score(up to 6 months)
  • Gastrointestinal endoscopy finding(up to 6 months)

研究者

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

Sun-Young Lee

Professor

Konkuk University Medical Center

研究点 (1)

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