Low-dose Rifaximin in the Treatment of Covert Hepatic Encephalopathy: A Randomized Open Controlled Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- health-related quality of life improvement
研究概览
简要总结
Several studies have been showed that rifaximin can improve cognitive functions, driving simulator performance and health-related quality of life in patients with minimal hepatic encephalopathy. The aim of this prospective randomized open controlled study was to evaluate the efficacy and safety of rifaximin at different doses for the treatment of covert hepatic encephalopathy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients agreed to sign the informed consents
- •Patients aged 18-70 years，males or females
- •Patients who were diagnosed with occult hepatic encephalopathy by PHES and Stroop tests
排除标准
- •Allergy to rifamycin/rifamutin/rifampin/rifapentine
- •Current or recent (<3 month) use of alcohol or can't stop drinking during the study period
- •Use of antibiotics within last 6 weeks
- •Use of lactulose/lactitol, probiotics, L-ornithine-L-aspart，zinc，metronidazole, neomycin, or rifaximin within last 6 weeks
- •Infection or gastrointestinal hemorrhage within last 6 weeks
- •Use of psychoactive drugs within last 6 weeks
- •Occurred overt hepatic encephalopathy within last 3 months
- •history of portosystemic shunt surgery or transjugular intrahepatic portosystemic shunt
- •Poor vision, color blindness or motor defects that interfere with the performance of psychometric tests
- •Other non-controllable neurological or psychiatric problems which may affect cognitive function such as Alzheimer's disease, Parkinson's disease or schizophrenia
- •Conformed or highly suspicious diagnosis of liver malignant tumors
- •Human immunodeficiency virus (HIV) infection
- •Uncontrolled hypertension, diabetes or other serious cardiac and pulmonary diseases
- •White blood cell count<1×10^9/L
- •Pregnancy and breastfeeding
- •Participated in other drug clinical trials within 3 months
- •The researchers thought it was not suitable for this clinical trial
研究组 & 干预措施
the high-dose rifaximin
The high-dose rifaximin group was given rifaximin 1200 mg/day for 8 weeks.
干预措施: Rifaximin (Drug)
the low-dose rifaximinl group
The low-dose rifaximin group was given rifaximin 800 mg/day for 8 weeks.
干预措施: Rifaximin (Drug)
the control group
The control group didn't receive rifaximin treatment
干预措施: Rifaximin (Drug)
结局指标
主要结局
health-related quality of life improvement
时间窗: up to 6 month
complete the questionnaire "sickness impact profile"
Percentage of patients showing covert hepatic encephalopathy reversal
时间窗: up to 6 months
the percentage of patients showing covert hepatic encephalopathy reversal
次要结局
未报告次要终点
研究者
Wei-Fen Xie
Director
Shanghai Changzheng Hospital