Intestinal Microbiome After Gastrectomy (DiGMA)
Surgical Gastric Cancer Treatment: Influence on Intestinal Microbiome
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.
研究概览
地位
条件
研究类型
注册 (实际的)
联系人和位置
学习地点
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Vilnius、立陶宛
- National Cancer Institute
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
学习计划
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
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Test group
Patients who underwent total or subtotal gastrectomy for the treatment of gastric cancer
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Control group 1
Patients who underwent endoscopic mucosal resection/submucosal dissection for the treatment of gastric cancer
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Control group 2
In-house relatives of Test group and Control group 1 participants
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Control group 3
Patients with long-term history of proton pump inhibitor usage
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Intestinal microbiome composition
大体时间：5 years after surgery
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Significant differences in the beta-diversity of the intestinal microbiome between Test group and Control groups
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5 years after surgery
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Intestinal microbiome composition (II)
大体时间：5 years after surgery
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Significant differences in the alpha-diversity of the intestinal microbiome between Test group and Control groups
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5 years after surgery
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Fecal calprotectin
大体时间：5 years after surgery
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Significant differences in intestinal inflammation measured by fecal calprotectin between Test group and Control groups
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5 years after surgery
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Fecal zonulin
大体时间：5 years after surgery
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Significant differences in intestinal permeability measured by fecal zonulin between Test group and Control groups
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5 years after surgery
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Serum LPS
大体时间：5 years after surgery
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Significant differences in serum LPS between Test group and Control groups
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5 years after surgery
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Serum sCD14
大体时间：5 years after surgery
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Significant differences in serum sCD14 between Test group and Control groups
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5 years after surgery
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Serum LBP
大体时间：5 years after surgery
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Significant differences in serum LBP between Test group and Control groups
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5 years after surgery
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Serum sCD163
大体时间：5 years after surgery
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Significant differences in serum sCD163 between Test group and Control groups
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5 years after surgery
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Serum sMR
大体时间：5 years after surgery
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Significant differences in serum sMR between Test group and Control groups
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5 years after surgery
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Serum CRP
大体时间：5 years after surgery
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Significant differences in serum CRP between Test group and Control groups
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5 years after surgery
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Serum DAO
大体时间：5 years after surgery
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Significant differences in serum DAO between Test group and Control groups
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5 years after surgery
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合作者和调查者
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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