To Assess Efficacy of Nutritional Therapy in Secondary Prophylaxis of Hepatic Encephalopathy Versus Lactulose in Patients With Liver Cirrhosis.

Study Overview
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Brief Summary
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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.

Official Title
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To Assess Efficacy of Nutritional Therapy in Secondary Prophylaxis of Hepatic Encephalopathy Versus Lactulose in Patients With Liver Cirrhosis- A Randomised Controlled Trial

Conditions
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Liver Cirrhosis

Intervention / Treatment
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* Dietary Supplement: Nutrition
* Drug: Lactulose
* Dietary Supplement: Diet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nutrional Therapy Group<br>Nutritional group- Protein of 1.5 gm/kg thrice daily for 6 months | Dietary Supplement: Nutrition<br>* Nutrional group-30 kcal/kg with 1.5 grm protein with protein supplements<br>|
| Active Comparator: Lactulose Group<br>Lactulose - 20 mL thrice daily (maximum) for 6 months | Drug: Lactulose<br>* Lactulose plus diet consumed by patient<br>Dietary Supplement: Diet<br>* Protein Powder 15 to 20 gm/meal/day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients develop hepatic encephalopathy in both groups |  | 6 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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 | 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 |