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To assess the effect of nutrition on the prevention of liver disease induced brain dysfunction

A Double Blind Randomized Controlled Study to assess Efficacy of Nutritional Therapy for Secondary Prophylaxis of Hepatic Encephalopathy in Cirrhosis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/08/026993
Enrollment
150
Registered
2020-08-05
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K70- Alcoholic liver disease Health Condition 2: K746- Other and unspecified cirrhosis ofliver

Interventions

Intervention1: Nutritional Therapy: 30-35kcal/kg/day, 1-1.5gm/kg/day protein for 6 months Control Intervention1: No nutritional therapy: Normal diet

Sponsors

Deptt of Gastroenterology
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

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 Alzheimerâ??s disease, Parkinsonâ??s disease and non hepatic Metabolic Encephalopathies. Receiving psychoactive drugs, promotility and hypomotility drugs Hepatocellular carcinoma Electrolyte abnormality (Serum sodium Intercurrent infection such as spontaneous bacterial peritonitis Patients of acute on chronic liver failure (ACLF).

Design outcomes

Primary

MeasureTime frame
Time taken for first breakthrough episode of Overt Hepatic EncephalopathyTimepoint: 0, 1month, 2 month, 3 month, 4 month, 5 month, 6 month

Secondary

MeasureTime frame
Improvement in Health related Quality of Life (HRQOL). Improvement in Anthropometry Parameters (mid arm circumference, triceps skin fold thickness, hand grip, skeletal muscle mass, body fat mass, percent body fat) Changes in serum cytokines (IL-1,6,10,18,TNF,Endotoxins) level at 6 months. Correlation of baseline arterial Ammonia levels, Psychometric test score, Critical Flicker Frequency values, Childâ??s score, MELD score with recurrence of Overt Hepatic Encephalopathy Timepoint: 6 months

Countries

India

Contacts

Public ContactDr Hardik Ahuja

GB Pant Institute of Post graduate Medical Education and Research

barjeshchandersharma@gmail.com9718599203

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026