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临床试验/NCT03418428
NCT03418428已完成不适用

Surgical Gastric Cancer Treatment: Influence on Intestinal Microbiome

Vilnius University1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2018年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
34
试验地点
1
主要终点
Intestinal microbiome composition

研究概览

简要总结

The gastric barrier plays a major role in the maintanance of the distal intestinal microbiome composition. It has been shown before that the use of gastric acid suppression medication, such as proton pump inhibitors, are associated with distinctive alterations of the intestinal microbiome. Foremost, the invasion of predominantly oral bacteria, like Veillonella and Streptococcus species, were a resurring finding in previous reports.

Gastric cancer treatment includes the total or subtotal resection of the stomach which can influence the gastric acid production. However, the influence by alterations in gastric milieu after this treatment on the composition of the intestinal microbiome is not well studied.

Therefore, the intestinal microbiome of patients after total or subtotal gastrectomy and its influence on intestinal inflammation and gut permeability will be studied.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

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

入选标准

  • age 18 years and above
  • history of radical removal of gastric cancer (Test group and Control group 1) or PPI (Control group 3)
  • informed consent

排除标准

  • chemotherapy or radiotherapy 12 months prior to inclusion
  • gastric stump cancer
  • usage of antibiotics, pro- pre or synbiotics, H2-blocker 1 month prior to inclusion
  • PPI use (except for Control group 3) 1 month prior to inclusion
  • history of radical removal of gastric cancer (Control group 2-3)
  • history of gastrointestinal tract resections (other than gastric)
  • recurrence of gastric cancer
  • current non-gastric malignancies

结局指标

主要结局

Intestinal microbiome composition

时间窗: 5 years after surgery

Significant differences in the beta-diversity of the intestinal microbiome between Test group and Control groups

次要结局

  • Intestinal microbiome composition (II)(5 years after surgery)
  • Fecal calprotectin(5 years after surgery)
  • Fecal zonulin(5 years after surgery)
  • Serum LBP(5 years after surgery)
  • Serum LPS(5 years after surgery)
  • Serum sMR(5 years after surgery)
  • Serum sCD14(5 years after surgery)
  • Serum sCD163(5 years after surgery)
  • Serum CRP(5 years after surgery)
  • Serum DAO(5 years after surgery)

研究者

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

Rimantas Bausys

Medical Doctor

Vilnius University

研究点 (1)

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