Liver Cirrhosis
Conditions
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.
Interventions
DIETARY_SUPPLEMENTNutrition
Nutrional group-30 kcal/kg with 1.5 grm protein with protein supplements
DRUGLactulose
Lactulose plus diet consumed by patient
DIETARY_SUPPLEMENTDiet
Protein Powder 15 to 20 gm/meal/day
Sponsors
Institute of Liver and Biliary Sciences, India
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
1. Liver cirrhosis (Child B or Child C class) 2. Age between 18-60 years 3. History of recovery from episodeof overt hepatic encephalopathy (West-Haven grade 1 and above) in last 12 months.
Exclusion criteria
1. Evidence of overt hepatic encephalopathy at the time of enrollment 2. History of taking lactulose, rifaximin, neomycin, metronidazole, L-Ornithine L-Aspartate or probiotics in past 7 days 3. Alcohol intake during past 6 weeks 4. Receiving secondary prophylaxis for spontaneous bacterial peritonitis 5. Previous transjugular intrahepatic portosystemic shunts or shunt surgery 6. 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 7. Receiving psychoactive drugs, promotility and hypomotility drugs 8. Hepatocellular carcinoma 9. Electrolyte abnormality (Serum sodium \<125meq/L or serum potassium \<2.5meq/L) 10. Intercurrent infection such as spontaneous bacterial peritonitis 11. Patients of acute on chronic liver failure (ACLF).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of patients develop hepatic encephalopathy in both groups | 6 Months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| 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). |
| Changes in serum cytokines (IL-1,6,10,18,TNF,Endotoxins,myostatin levels) | 6 Months | — |
| Changes in Stool microbiota for 20 patients | 6 Months | — |
| Mortality over 6 months | 6 Months | — |
Countries
India
Outcome results
None listed