Effects of Probiotics on Metabolism of Uremic Toxin in Patients With End Stage Renal Disease (ESRD)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 6
- 主要终点
- Changes in Microbiota-derived uremic toxin
研究概览
简要总结
The purpose of this study is to investigate the effects of oral administration of probiotics on the metabolism of uremic toxins, in the patients with End Stage Renal Disease (ESRD). One hundred and fifty hemodialysis patients are recruited, and a Double Blind Randomized Parallel Controlled Trial was performed.The microbiota-derived uremic toxin, such as indoxyl sulfate and p-cresol sulfate, are measured as Primary Outcome. The Fecal microbiome, fecal metabolites, blood metabolites, defecation, Gastrointestinal Symptoms The Kidney Disease Quality of Life and The Occurrence of Cardiovascular Event are also assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age over 18 years old
- •Patients who diagnosed as ESRD with hemodialysis
- •Fixed hemodialysis cycle (average 3 times a week)
- •Agree to take the products to be studied during the study period, and no longer take other fermented dairy products (live lactic acid bacteria drinks, cheese, yogurt, probiotic products, etc.)
- •Agree to sign the informed consent form
排除标准
- •Taking antibiotics or antifungal drugs within 30 days before the study
- •Have serious allergic reaction to skim milk powder
- •Researcher 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
Changes in Microbiota-derived uremic toxin
时间窗: 6 months
follow up the patients at Month 0, 3, 6
次要结局
- Changes in Fecal Microbiome(6 months)
- Changes in Fecal metabolites(6 months)
- Changes in Blood metabolites(6 months)
- Defecation questionnaire(6 months)
- The Occurrence of Cardiovascular Event(6 month follow-up)
- Gastrointestinal Symptoms(6 months)
- The Kidney Disease Quality of Life(6 months)
研究者
Fazheng Ren
Professor
China Agricultural University