DRKS00006359进行中（未招募）4 期
Minimal hepatic encephalopathy (MHE) – influence of therapy with rifaximin on MHE and on the intestinal microbiome in patients with liver cirrhosis – the RiMINI-Trial - RiMINI
Medizinische Fakultät der Otto-von-Guericke Universität0 个研究点目标入组 5 人开始时间: 2015年11月25日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 5
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 90 Years（—）
- 性别
- All
入选标准
- •1. Male and female individuals 18 - 90 years of age at the time of enrollment who are mentally competent, willing and able to understand the nature and risks of the proposed study, and able to sign the consent form prior to study entry;
- •2. Individuals with a projected life expectancy of 6 months or longer;
- •3. Individuals who are able to comply with all study procedures and requirements;
- •4. Female subjects with childbearing potential who have negative pregnancy test during screening period.
- •5. diagnosis of liver cirrhosis, established either by histology or by typical signs in transabdominal ultrasound in combination with signs of portal hypertension (ascites, enlarged spleen, fundic or esophageal varices)
- •6. presence of minimal hepatic encephalopathy (MHE)
排除标准
- •Individuals with one of the following medical conditions:
- •1. Documented underlying allergic condition against rifaximin or lactulose
- •2. Underlying blindness or eye axis deviation or red- green- color- blindness
- •3. Individuals with a projected life expectancy of less than 6 months
- •4. overt hepatic encephalopathy
- •5. antibiotic treatment within 28 days before study entry or during the study
- •6. Individuals who are not in sufficient health status as determined by the outcome of medical history, physical assessment, and clinical judgment of the investigator.
- •7. Individuals who are not able to follow the required study procedures for the whole period of the study.
- •8. Individuals with behavioral or cognitive impairment or psychiatric disease that, in the opinion of the investigator, may interfere with the subject´s ability to participate in the trial.
- •9. Individuals who are planned to be hospitalized or undergo surgery during the study period.
- •10. Individuals who have participated in another clinical study within 30 days prior enrollment into the study.
- •11. Individuals with ongoing drug- or alcohol abuse that, in the opinion of the investigator, would interfere with the safety of the subject or the evaluation of the study objectives.
- •12. Individuals who are member of the research staff or have relatives who are member of the research staff.
- •13. Female subjects with childbearing potential who have positive pregnancy test during screening period. Female subjects no use of common contraceptive methods. Pregnant and lactating women.
- •14. Individuals with a medical history or any illness that may, in the opinion of the investigator, pose additional risk to the subject due to participation in the study.
研究者
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