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临床试验/NCT01178372
NCT01178372Unknown4 期

Secondary Prophylaxis of Hepatic Encephalopathy in Cirrhosis: An Open Label, Randomized Controlled Trial of Lactulose, Probiotics and No-therapy

Govind Ballabh Pant Hospital1 个研究点 分布在 1 个国家开始时间: 2008年9月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
试验地点
1
主要终点
episode of overt hepatic encephalopathy

研究概览

简要总结

Hepatic encephalopathy (HE), a challenging complication of advanced liver disease, occurs in approximately 30-45% of patients with cirrhosis. The treatment of choice is non-absorbable disaccharides, such as lactulose and lactitol.Probiotics are effective in the treatment of minimal hepatic encephalopathy which precipitates hepatic encephalopathy. The investigators will assess the effects of lactulose and probiotics for the prevention of recurrence of HE (secondary prophylaxis) in patients after the recovery of an episode of overt hepatic encephalopathy.

详细描述

Hepatic encephalopathy, a challenging complication of advanced liver disease, occurs in approximately 30-45% of patients with cirrhosis and 10-50% of patients with transjugular intrahepatic portosystemic shunt.Although the occurrence of episodes of hepatic encephalopathy appears to be unrelated to the cause of cirrhosis,increases in the frequency and severity of such episodes predict an increased risk of death.A small metaanalysis determined that lactulose and lactitol were equally effective in the treatment of HE.Probiotics alter the gut flora resulting in decreased ammonia production and absorption due to decreased intraluminal pH. Also shown to alter the short chain fatty acid production, & decrease intestinal permeability.Various studies have shown some improvement in either the prevalence of minimal hepatic encephalopathy or results in neuropsychological tests with the use of probiotics.Lactulose and probiotics improves minimal hepatic encephalopathy in cirrhotic patients and it has also been shown that minimal hepatic encephalopathy predisposes the cirrhotic patient to HE.We will assess the effects of lactulose and probiotics for the prevention of recurrence of hepatic encephalopathy (secondary prophylaxis) in patients after the recovery of an episode of overt hepatic encephalopathy.

研究设计

研究类型
Interventional

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

入选标准

  • Patients with cirrhosis and previous history of recovery from hepatic encephalopathy

排除标准

  • history of taking lactulose in the past 6 weeks.
  • alcohol intake during the past 6 weeks or during follow up
  • patients on secondary prophylaxis for spontaneous bacterial peritonitis
  • previous TIPS or shunt surgery
  • significant comorbid illness such as heart, respiratory, or renal failure
  • any neurologic diseases such as alzheimer's disease, parkinson's disease and nonhepatic metabolic encephalopathies.

研究组 & 干预措施

probiotics

Active Comparator

干预措施: Probiotics(VSL#3) (Drug)

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

干预措施: Lactulose (Drug)

结局指标

主要结局

episode of overt hepatic encephalopathy

时间窗: 6 months

次要结局

  • side effects to therapy(6 months)

研究者

申办方类型
Other Gov

研究点 (1)

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