NCT01069133已完成1 期
Effect of Rifaximin Therapy on Brain Activation in Patients With Minimal Hepatic Encephalopathy Using Functional MR, MR Spectroscopy,Diffusion Tensor Imaging Microbiome and Metabolome: a Prospective Trial
Hunter Holmes Mcguire Veteran Affairs Medical Center1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2010年2月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- brain activation on fMRI
研究概览
简要总结
Rifaximin therapy will improve brain functioning on MRI scanning and change the microbiome and metabolome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-65 years
- •cirrhosis diagnosed by clinical or biopsy grounds
- •Minimal hepatic encephalopathy defined by impaired performance on at least 2 of the following: number connection tests A/B, digit symbol and block design tests (NCT-A, NCT-B, DST and BDT) compared to age and education-matched controls.
- •No contraindications to MRI
- •TIPS (transjugular intra-hepatic porto-systemic shunt) procedure or elective surgery planned within the next 8 weeks
排除标准
- •Current therapy with lactulose, rifaximin or other treatment for hepatic encephalopathy.
- •Prior episodes of overt HE
- •MMSE <25
- •TIPS placement
- •Unable to give informed consent.
- •Contra-indications to MRI
研究组 & 干预措施
Rifaximin
Experimental
干预措施: rifaximin (Drug)
结局指标
主要结局
brain activation on fMRI
时间窗: 2 months
Microbiome constituents
时间窗: 8 weeks
次要结局
- brain edema and brain metabolite concentration(2 months)
- Metabolome of urine and serum(8 weeks)
研究者
Jasmohan Bajaj
Associate Professor of Medicine
Hunter Holmes Mcguire Veteran Affairs Medical Center
研究点 (1)
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