To assess the effect of nutrition on the prevention of liver disease induced brain dysfunctio
- Conditions
- Health Condition 1: K70- Alcoholic liver diseaseHealth Condition 2: K746- Other and unspecified cirrhosis ofliver
- Registration Number
- CTRI/2020/08/026993
- Lead Sponsor
- Deptt of Gastroenterology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Liver cirrhosis (Child B or Child C class)
Age between 18-60 years
History of recovery from episode of 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 Alzheimerâ??s disease, Parkinsonâ??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
- Not specified
- Primary Outcome Measures
Name Time Method Time taken for first breakthrough episode of Overt Hepatic EncephalopathyTimepoint: 0, 1month, 2 month, 3 month, 4 month, 5 month, 6 month
- Secondary Outcome Measures
Name Time Method Improvement in Health related Quality of Life (HRQOL). <br/ ><br>Improvement in Anthropometry Parameters (mid arm circumference, triceps skin fold thickness, hand grip, skeletal muscle mass, body fat mass, percent body fat) <br/ ><br>Changes in serum cytokines (IL-1,6,10,18,TNF,Endotoxins) level at 6 months. <br/ ><br>Correlation of baseline arterial Ammonia levels, Psychometric test score, Critical Flicker Frequency values, Childâ??s score, MELD score with recurrence of Overt Hepatic Encephalopathy <br/ ><br> <br/ ><br>Timepoint: 6 months