跳至主要内容
临床试验/NCT01752738
NCT01752738招募中不适用

The Influence of Chronic Kidney Disease on Intestinal Transport of Gut Microbial Metabolites

Universitaire Ziekenhuizen KU Leuven1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2013年12月最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
20
试验地点
1
主要终点
Percentage change in number of intestinal drug transporters and enzymes

研究概览

简要总结

Chronic kidney disease is associated with the accumulation of various metabolites, i.e., uremic retention solutes. Evidence is mounting that the colonic microbiome contributes substantially to these uremic retention solutes. Indoxyl sulfate and p-cresyl sulfate are among the most extensively studied gut microbial metabolites, and are associated with cardiovascular disease, chronic kidney disease progression and overall mortality. Mechanisms governing their intestinal uptake and metabolism, however, are currently unknown. The investigators aim to explore these transport characteristics in depth. Therefore, colonic biopsies will be sampled of patients with chronic kidney disease, analyzed and compared to available data of healthy controls. Insights in the mechanisms controlling intestinal transport and metabolism of indoxyl sulfate and p-cresyl sulfate is certainly relevant as it might lead to novel therapeutic targets in the treatment of chronic kidney disease.

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 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥ 18 and ≤ 85 years
  • Chronic kidney disease ≤ stage III (KDOQI), i.e., estimated glomerular filtration rate (MDRD) < 60 ml/min/m² or need of dialysis therapy 27
  • Scheduled colonoscopy for diagnostic purposes
  • Written informed consent

排除标准

  • History of gastro-intestinal disease (e.g., inflammatory bowel disease)
  • History of colon surgery
  • Recipient of a renal or other solid organ transplant
  • Exposure to antibiotics or drug therapy with a known influence on intestinal transporters (e.g., P-gp) or enzymes during 2 weeks before colonoscopy

结局指标

主要结局

Percentage change in number of intestinal drug transporters and enzymes

时间窗: 4 years

Influence of chronic kidney disease on intestinal drug transporters and enzymes responsible for uptake and metabolism of microbial metabolites

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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