NCT03010696已完成不适用
The Correlation Between Gut Microbiome/Metabolite and End Stage Renal Disease (ESRD)
China Agricultural University4 个研究点 分布在 1 个国家目标入组 293 人开始时间: 2015年6月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 293
- 试验地点
- 4
- 主要终点
- Microbiota-derived uremic toxin
研究概览
简要总结
The purpose of this study is to investigate the differences of gut Microbiome/Metabolite between ESRD patients and healthy subjects. Two hundred and twenty three hemodialysis patients and 70 healthy subjects are recruited, and a cross-sectional study is performed.
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
- 是
入选标准
- •Age over 18 years old
- •Liver and kidney function is normal
- •18.5≤BMI≤29.9
- •Agree to sign the informed consent form
排除标准
- •Diagnosed as Metabolic syndrome
- •Diagnosed as Cirrhosis
- •Diagnosed as kidney disease
- •Taking fermented food (live lactic acid bacteria drinks, cheese, yogurt, probiotic products, etc.) within 14 days before the study
- •Taking antibiotics or antifungal drugs within 30 days before the study
- •For ESRD patients
- •Inclusion criteria:
- •Age over 18 years old
- •Patients who diagnosed as ESRD with hemodialysis
- •Fixed hemodialysis cycle (average 3 times a week)
- •Agree to sign the informed consent form
- •Exclusion criteria:
- •Taking antibiotics or antifungal drugs within 30 days before the study
- •Taking fermented food (live lactic acid bacteria drinks, cheese, yogurt, probiotic products, etc.) within 14 days before the study
- •Reasercher are not sure whether the subjects are willing or able to complete the study
- •Subject participated in other research projects within two months before the study
结局指标
主要结局
Microbiota-derived uremic toxin
时间窗: Through study completion, an average of 1 year
次要结局
- Fecal Microbiome(Through study completion, an average of 1 year)
- Complete blood count(Through study completion, an average of 1 year)
- Fecal metabolites(Through study completion, an average of 1 year)
- Blood metabolites(Through study completion, an average of 1 year)
- Blood biochemistry test(Through study completion, an average of 1 year)
研究者
Fazheng Ren
Professor
China Agricultural University
研究点 (4)
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