Comparison Between Lactulose and Lactulose-Paraffin in Cirrhotic Patients: Impact on the Recurrence of Encephalopathy, Tolerance and Adherence to Treatment, Costs, and Quality of Life
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Adherence to treatment
研究概览
简要总结
Hepatic encephalopathy (HE) is an important complication of liver cirrhosis. Lactulose is a first line treatment for HE, but the adherence to this treatment is relatively low, due to side effects such as diarrhea, distention, etc.
详细描述
Lactulose is a first line treatment for HE, but the adherence to this treatment is relatively low due to side effects. Lactulose-paraffin recently available in the market can be used for the treatment of HE, and possibly have fewer side effects.
The aim of this study was to compare the adherence of the treatment of lactulose and lactulose-paraffin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Liver cirrhosis
- •History of an event of hepatic encephalopathy.
- •Ambulatory patients
排除标准
- •Alcoholism with active ingest of alcohol in the last 6 months
- •Labour turn-overs
- •Pregnancy
- •Personal history of surgery in the last 4 weeks
- •Spontaneous bacterial Peritonitis
- •Use of neuropsychiatric drugs
- •Neuropsychiatric disorders (Schizophrenia, bipolar disorder, major depression, dementia and Attention-deficit hyperactivity disorder)
- •Thyroid disorders without replacement therapy
- •Renal failure
- •Hepatic or renal transplant
- •Personal history of hepatocellular carcinoma
- •Placement of transjugular intrahepatic portosystemic shunt
- •Use of a probiotic in the last 6 month
研究组 & 干预措施
Lactulose
Lactulose 15ml oral intake 8hrs daily for 6 months. The dose may be modified depending on the number of total bowel movements, (the expected range is 2 - 4 per day).
干预措施: Comparison between Lactulose and Lactulose-Paraffin (Drug)
Lactulose-paraffin
Paraffin 15g daily for 6 months. The dose may be modified depending on the number of total bowel movements, (the expected range is 2 - 4 per day).
干预措施: Comparison between Lactulose and Lactulose-Paraffin (Drug)
结局指标
主要结局
Adherence to treatment
时间窗: 6 months
Provide evidence of better adherence to treatment with lactulose-paraffin in cirrhotic patients with a history of hepatic encephalopathy, which should be reflected in fewer hospitalizations, lower costs and better quality life.
次要结局
未报告次要终点
研究者
ALDO TORRE DELGADILLO
Principal Investigator.
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran