The Effect of an Antibiotic on the Production of Uremic Toxins by the Gut Microbiome
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Change in Plasma Concentration Measure P-Cresyl Sulphate (PCS)
研究概览
简要总结
The purpose of this study is to determine if multiple doses of vancomycin over the course of 3 months will perturb the intestinal flora (microbiome) and result in reduced serum concentration of the uremic toxin indoxyl sulfate and p-cresyl sulfate. The design of the study will permit investigators to assess the variability of serum uremic retention solute concentrations with and without antibiotic over a three-month period.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with stable chronic kidney disease on hemodialysis with a fistula or an AV graft.
排除标准
- •Antibiotics received within the last 3 months;
- •recent diarrhea
- •known allergy to vancomycin
- •history of C. difficile infection
- •elevation of white blood cell count or fever within one week of enrollment.
研究组 & 干预措施
250mg of oral vancomycin First
After 3 months, initial experimental group will be switched to placebo for 3 months.
干预措施: Vancomycin (Drug)
250mg of oral vancomycin First
After 3 months, initial experimental group will be switched to placebo for 3 months.
干预措施: Placebo (Other)
Placebo First
After three months, the control group will be crossed over to weekly oral vancomycin (250mg)
干预措施: Vancomycin (Drug)
Placebo First
After three months, the control group will be crossed over to weekly oral vancomycin (250mg)
干预措施: Placebo (Other)
结局指标
主要结局
Change in Plasma Concentration Measure P-Cresyl Sulphate (PCS)
时间窗: 4 weeks
Plasma concentrations of P-Cresyl Sulphate (PCS) were measured by HPLC (high pressure liquid chromatography) Assessed weekly between day 0 and Week 4; change from baseline/day 0 to Week 4 reported
Change in Plasma Concentration Measure of Indoxyl Sulphate (IS)
时间窗: 4 weeks
Plasma concentrations of IS were measured by HPLC (high pressure liquid chromatography). Assessed weekly between day 0 and Week 4; change from baseline/day 0 to Week 4 reported
次要结局
未报告次要终点