To Assess Efficacy of Nutritional Therapy in Secondary Prophylaxis of Hepatic Encephalopathy Versus Lactulose in Patients With Liver Cirrhosis.
- Conditions
- Liver Cirrhosis
- Interventions
- Registration Number
- NCT03161106
- Lead Sponsor
- Institute of Liver and Biliary Sciences, India
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- 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.
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Nutrional Therapy Group Nutrition Nutritional group- Protein of 1.5 gm/kg thrice daily for 6 months Lactulose Group Diet Lactulose - 20 mL thrice daily (maximum) for 6 months Lactulose Group Lactulose Lactulose - 20 mL thrice daily (maximum) for 6 months
- Primary Outcome Measures
Name Time Method Number of patients develop hepatic encephalopathy in both groups 6 Months
- Secondary Outcome Measures
Name Time Method Improvement in health related quality of life over 6 months 6 Months Improvement will be defined on the basis of HRQOL (Health Related Quality of Life Index).
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 Improvement will be measured by dexa scan , C T scan and by measuring mid arm circumference, triceps skin fold thickness, hand grip
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
Trial Locations
- Locations (1)
Institute of Liver and Biliary Sciences
🇮🇳New Delhi, Delhi, India