NCT02342639已完成4 期
Impact of Rifaximin Therapy on Intestinal Byproducts in Chronic Kidney Disease
Jason Stubbs, MD1 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2015年6月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Change in Serum Trimethylamine N-oxide (TMAO)
研究概览
简要总结
The purpose of this study is to determine if Rifaximin decreases serum and urine levels of bacterial byproducts and inflammatory markers in patients with chronic kidney disease and to evaluate changes in the bacterial content of the stool from these individuals.
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
- Triple (Participant, 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
- •Chronic kidney disease with eGFR ≤ 39 ml/min/1.73m2
排除标准
- •Patients with normal renal function or those with less advanced kidney disease
- •Inability or unwillingness to provide consent
- •Patients undergoing hemodialysis or peritoneal dialysis therapy or those who have undergone organ transplant
- •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, bile acid sequestrants and current or recent (within the last 3 months) use of antibiotics
研究组 & 干预措施
Rifaximin
Experimental
Participants will receive a 10-day course of Rifaximin.
干预措施: Rifaximin (Drug)
Placebo
Placebo Comparator
Participants will receive a 10-day course of placebo.
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Serum Trimethylamine N-oxide (TMAO)
时间窗: Change from baseline to Day 11
次要结局
- C-reactive Protein(Change from baseline to Day 11)
- Change in Serum Interleukin-6 (IL-6)(Change from baseline to day 11)
研究者
Jason Stubbs, MD
Associate Professor
University of Kansas Medical Center
研究点 (1)
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