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临床试验/NCT02141815
NCT02141815已完成不适用

The Effect of Arabinoxylan-oligosaccharides (AXOS) on Intestinal Generation of Microbial Metabolites in Chronic Kidney Disease

Universitaire Ziekenhuizen KU Leuven2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2014年5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
40
试验地点
2
主要终点
Serum levels of p-cresol and indole derivatives

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 microbiota 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, overall mortality and chronic kidney disease progression. The most important regulator of colonic bacterial metabolism is nutrient availability and especially the ratio of available fermentable carbohydrate to nitrogen, which can be modified by intake of so-called prebiotics (non-digestible food ingredients). Arabinoxylan oligosaccharides (AXOS) are a recently developed group of prebiotics, and already demonstrated a decreasing effect on intestinal generation of p-cresol in healthy individuals. Whether prebiotics in general, and AXOS more specifically, can influence intestinal generation of microbial metabolites in predialysis patients has not been studied to date. An interventional study with AXOS will therefore be initiated to test the hypothesis that AXOS can decrease intestinal generation and serum concentrations of microbial metabolites in patients with CKD not yet on dialysis.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

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 3b-4, i.e., with estimated glomerular filtration rate (CKD-epi) between 45 - 15 ml/min/m² 29
  • 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

Serum levels of p-cresol and indole derivatives

时间窗: After 4 weeks of intervention

次要结局

  • Insuline resistance(After 4 weeks of intervention)
  • Urinary excretion rates of p-cresol and indole derivatives(After 4 weeks of intervention)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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