NCT02738905撤回早期 1 期
Impact of Rifaximin Therapy on Intestinal Byproducts in End-Stage Renal Disease
Jason Stubbs, MD2 个研究点 分布在 1 个国家开始时间: 2016年1月最近更新:
适应症
干预措施
试验速览
- 阶段
- 早期 1 期
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- Change in serum TMAO levels
研究概览
简要总结
The purpose of this study is to determine if rifaximin reduces serum trimethylamine-N-oxide (TMAO) levels in patients with end-stage renal disease.
详细描述
Study participants will undergo 3 study visits: baseline, day 7 (immediately post-therapy), day 21 (2 weeks post-therapy). All participants will provide blood and stool samples at each visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Diagnosis of end-stage renal disease
- •Receiving chronic intermittent hemodialysis
排除标准
- •Patients with less advanced kidney disease
- •Inability or unwillingness to provide informed consent
- •Patients who may be pregnant
- •Hemodynamically unstable patients
- •Patients with liver failure, pancreatic insufficiency, or inflammatory bowel disease
- •Patients with ongoing or recent infection and those with history of C-diff infection
- •Patients with abnormal bowel structure secondary to surgical or anatomic variations
- •Patients on certain medications, including immunosuppressants, antidiarrheal agents, or recent (within the last 2 months) use of antibiotics
研究组 & 干预措施
Rifaximin
Experimental
Participants will receive study drug for a period of 7 days.
干预措施: Rifaximin (Drug)
结局指标
主要结局
Change in serum TMAO levels
时间窗: Change from Baseline to Day 7
次要结局
- Change in fecal bacterial species(Change from Baseline to Day 21)
- Change in serum TMAO levels(Change from Baseline to Day 21)
- Change in fecal bacterial colony numbers(Change from Baseline to Day 21)
研究者
Jason Stubbs, MD
Associate Professor
University of Kansas Medical Center
研究点 (2)
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