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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Institute of Liver and Biliary Sciences
New Delhi, National Capital Territory of Delhi, India
Number of patients develop hepatic encephalopathy in both groups
Time frame: 6 Months
Improvement in health related quality of life over 6 months
Improvement will be defined on the basis of HRQOL (Health Related Quality of Life Index).
Time frame: 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
Improvement will be measured by dexa scan , C T scan and by measuring mid arm circumference, triceps skin fold thickness, hand grip
Time frame: 6 Months
Time taken for first breakthrough episode of overt hepatic encephalopathy
Time frame: 6 Months
Time to first overt hepatic encephalopathy-related hospital admission
Time frame: 6 Months
Mortality over 6 months
Time frame: 6 Months
Changes in serum cytokines (IL-1,6,10,18,TNF,Endotoxins,myostatin levels)
Time frame: 6 Months
Changes in Stool microbiota for 20 patients
Time frame: 6 Months
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