NCT04787276已完成不适用
Probiotic E.Coli Nissle 1917 Comparing to Lactulose and Rifaximin in Patients With Mild (Stage 1-2) or Minimal Hepatic Encephalopathy
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 主要终点
- Change in serum ammonia
研究概览
简要总结
The purpose of study to assess the short-term efficacy and safety of probiotic E.coli Nissle 1917 strain comparing to lactulose and rifaximin in patients with mild (Stage 1-2) or minimal 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
- 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
- •Cirrhosis diagnosed on the basis of liver biopsy, liver stiffness measurement or radiological study;
- •presence of minimal or mild (Grade 1-2) HE as defined by West Haven criteria;
- •two or more documented episodes of HE in the last 6 months, in addition to at least one episode in the last 3 months;
- •subject is capable and willing to comply with all study procedures;
- •signed inform consent.
排除标准
- •history of taking L-ornithine- L -aspartate, zinc, metronidazole, or neomycin, antibiotics, probiotics and yogurt consumption within 6 weeks;
- •subject has a history of allergy or intolerance to lactulose and/or rifaximin;
- •alcohol intake during the past 6 month or during follow up;
- •recent (6 weeks) gastro-intestinal bleed;
- •hepato-cellular carcinoma or liver transplantation;
- •renal insufficiency;
- •significant comorbid illness such as heart or respiratory failure;
- •concurrent infection such as spontaneous bacterial peritonitis, pneumonia or urinary tract infection;
- •any neurologic diseases such as alzheimer's disease, parkinson's disease and nonhepatic metabolic encephalopathies;
- •subject has any condition or circumstance that would, in the opinion of the Investigator, prevent completion of the study or interfere with analysis of study results, including history of noncompliance with treatments.
研究组 & 干预措施
E.coli Nissle 1917
Experimental
probiotic, oral, for the first 4 days, 1 capsule, and then 2 capsules per day for 1 month treatment
干预措施: E.coli Nissle 1917 (Dietary Supplement)
Lactulose
Active Comparator
will receive 30-60 ml of lactulose in 2 or 3 divided doses so that patient passed 2-3 semisoft stools per day, 1 months of treatment
干预措施: Lactulose (Drug)
Rifaximin
Active Comparator
rifaximin, oral, 500 mg BID, 1 months of treatment
干预措施: Rifaximin (Drug)
结局指标
主要结局
Change in serum ammonia
时间窗: 1 month
Change in Stroop test
时间窗: 1 month
次要结局
- Change in serum inflammatory cytokine(1 month)
- Bacteriology measured in the stool flora by specialized non-culture techniques(1 month)
研究者
Nazarii Kobyliak
Associate Professor, Endocrinology Department
Bogomolets National Medical University
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