NCT00831337已完成不适用
The Study of Probiotics in Liver Cirrhosis Patients With Portal Hypertension.
Pomeranian Medical University Szczecin2 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2007年4月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 33
- 试验地点
- 2
- 主要终点
- Laboratory data
研究概览
简要总结
This study is to evaluate the role of probiotics in the treatment of portal hypertension. In particular the role of probiotics on gut microbiota in liver cirrhosis patients will be studied and compared with cytokines and other substances implicated in the pathogenesis of portal hypertension. The hypothesis whether probiotics may change the prognosis of patients with portal hypertension will be studied. The hypothesis whether probiotics may halt the pathologic cascade of events leading to various complications (e.g. hepato-renal syndrome, spontaneous bacterial peritonitis, bleeding varices) will be reviewed.
详细描述
Studied probiotics: VSL3
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Confirmed liver cirrhosis (liver biopsy or typical imaging studies)
- •Confirmed portal hypertension
- •18 years and older
- •compliant patients
排除标准
- •Antibiotic treatment in last 3 months
- •Lactulose treatment in last 3 months
- •Patients taking NSAIDS in lat 3 months
- •Steroid treatment in last 3 months
- •Ongoing and active infection
- •Pregnant woman
- •Cancer diagnosis
- •decompensated diabetes mellitus
- •active or past treatment with recombinant cytokines (e.g. anty TNF, interferon etc)
- •medication altering function of CNS, suffering from neurological or ophthalmological conditions
- •initiating the therapy with beta blockers within the prior 12 weeks
- •mental disease
结局指标
主要结局
Laboratory data
时间窗: 28 days
次要结局
- Clinical and laboratory data(1 months)
研究者
Wojciech Marlicz
MD PhD
Pomeranian Medical University Szczecin
研究点 (2)
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