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临床试验/NCT01874210
NCT01874210已完成不适用

Study on Colonic Fermentation in Chronic Kidney Disease Patients

Universitaire Ziekenhuizen KU Leuven1 个研究点 分布在 1 个国家目标入组 65 人开始时间: 2008年2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
65
试验地点
1
主要终点
difference in fecal metabolite profile (Chronic kidney disease vs. control)

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. Indirect findings suggest that chronic kidney disease influences the colonic microbial metabolism with higher p-cresyl sulfate urinary excretion rates at more advanced renal disease. Therefore, this study aims to elucidate the influence of renal dysfunction on microbial metabolism and to test the hypothesis that chronic kidney disease patients carry a different fecal metabolite profile.

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

入选标准

  • Age ≥ 18 and ≤ 95 years
  • Treatment with renal replacement therapy, i.e. hemo- or peritoneal dialysis for more than 3 months
  • Written informed consent

排除标准

  • History of organic gastro-intestinal disease (e.g., inflammatory bowel disease, malignancy)
  • History of colonic surgery
  • Recipient of a renal or other solid organ transplant
  • Use of pre-/pro-/syn- or antibiotics in preceding 4 weeks

结局指标

主要结局

difference in fecal metabolite profile (Chronic kidney disease vs. control)

时间窗: baseline

difference in fecal metabolite profile between chronic kidney disease patients and control group

次要结局

  • difference in fecal metabolite profile depending on dialysis modality(baseline)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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