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

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

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 Overview

• Status: Withdrawn
• Conditions: Liver Cirrhosis
• Intervention / Treatment: Dietary supplement: Nutrition; Drug: Lactulose; Dietary supplement: Diet

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Delhi
    • New Delhi, Delhi, India, 110070
      • Institute of liver and Biliary Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Institute of Liver and Biliary Sciences, India

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2017
• Primary Completion (Anticipated): October 1, 2018
• Study Completion (Anticipated): October 1, 2018

Study Registration Dates

• First Submitted: May 8, 2017
• First Submitted That Met QC Criteria: May 17, 2017
• First Posted (Actual): May 19, 2017

Study Record Updates

• Last Update Posted (Actual): December 11, 2018
• Last Update Submitted That Met QC Criteria: December 8, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Failure; Hepatic Insufficiency; Pathologic Processes; Metabolic Diseases; Central Nervous System Diseases; Nervous System Diseases; Liver Diseases; Brain Diseases, Metabolic; Fibrosis; Liver Cirrhosis; Hepatic Encephalopathy; Brain Diseases; Gastrointestinal Agents; Lactulose
• Other Study ID Numbers: ILBS-Cirrhosis-12

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No