To Assess Efficacy of Nutritional Therapy in Secondary Prophylaxis of Hepatic Encephalopathy Versus Lactulose in Patients With Liver Cirrhosis- A Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Number of patients develop hepatic encephalopathy in both groups
研究概览
简要总结
The study will be conducted on patients attending /admitted to Department of Hepatology from April 2017 to December 2018 at ILBS, New Delhi .
Clinical, anthropometric and biochemical assessment will be done by candidate, co-supervisors and supervisor. Patients in treatment group will receive nutritional therapy in the form of 30-kcal/kg/day and 1.5gm/kg/day protein with supplements. Other patients will continue diet that they were receiving before along with lactulose. Previous treatment and prophylaxis of variceal bleed any (endoscopic variceal ligation or beta blocker) will be continued as before. All subjects will be followed up every month for treatment compliance and for development of any complications.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Liver cirrhosis (Child B or Child C class)
- •Age between 18-60 years
- •History of recovery from episodeof overt hepatic encephalopathy (West-Haven grade 1 and above) in last 12 months.
排除标准
- •Evidence of overt hepatic encephalopathy at the time of enrollment
- •History of taking lactulose, rifaximin, neomycin, metronidazole, L-Ornithine L-Aspartate or probiotics in past 7 days
- •Alcohol intake during past 6 weeks
- •Receiving secondary prophylaxis for spontaneous bacterial peritonitis
- •Previous transjugular intrahepatic portosystemic shunts or shunt surgery
- •Significant comorbid illness such as heart, respiratory or kidney failure, and neurological disease such as Alzheimer's disease, Parkinson's disease and non hepatic metabolic encephalopathies
- •Receiving psychoactive drugs, promotility and hypomotility drugs
- •Hepatocellular carcinoma
- •Electrolyte abnormality (Serum sodium <125meq/L or serum potassium <2.5meq/L)
- •Intercurrent infection such as spontaneous bacterial peritonitis
- •Patients of acute on chronic liver failure (ACLF).
研究组 & 干预措施
Nutrional Therapy Group
Nutritional group- Protein of 1.5 gm/kg thrice daily for 6 months
干预措施: Nutrition (Dietary Supplement)
Lactulose Group
Lactulose - 20 mL thrice daily (maximum) for 6 months
干预措施: Lactulose (Drug)
Lactulose Group
Lactulose - 20 mL thrice daily (maximum) for 6 months
干预措施: Diet (Dietary Supplement)
结局指标
主要结局
Number of patients develop hepatic encephalopathy in both groups
时间窗: 6 Months
次要结局
- Improvement in health related quality of life over 6 months(6 Months)
- Improvement in anthropometry parameters (mid arm circumference, triceps skin fold thickness, hand grip), skeletal muscle mass, body fat mass, percent body fat,BMI over 6 months(6 Months)
- Time taken for first breakthrough episode of overt hepatic encephalopathy(6 Months)
- Time to first overt hepatic encephalopathy-related hospital admission(6 Months)
- Mortality over 6 months(6 Months)
- Changes in serum cytokines (IL-1,6,10,18,TNF,Endotoxins,myostatin levels)(6 Months)
- Changes in Stool microbiota for 20 patients(6 Months)