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

NCT03161106 | Withdrawn

• 1 other identifier: ILBS-Cirrhosis-12
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Cirrhosis

Outcome Measures

Primary Outcomes (1)

• Number of patients develop hepatic encephalopathy in both groups

  6 Months

Secondary Outcomes (7)

• Improvement in health related quality of life over 6 months

  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

  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

Study Arms (2)

Nutrional Therapy Group

EXPERIMENTAL

Nutritional group- Protein of 1.5 gm/kg thrice daily for 6 months

Dietary Supplement: Nutrition

Lactulose Group

ACTIVE COMPARATOR

Lactulose - 20 mL thrice daily (maximum) for 6 months

Drug: Lactulose; Dietary Supplement: Diet

Interventions

Nutrition DIETARY_SUPPLEMENT

Nutrional group-30 kcal/kg with 1.5 grm protein with protein supplements

Nutrional Therapy Group

Lactulose DRUG

Lactulose plus diet consumed by patient

Lactulose Group

Diet DIETARY_SUPPLEMENT

Protein Powder 15 to 20 gm/meal/day

Lactulose Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Institute of Liver and Biliary Sciences, India: lead

Study Sites (1)

Institute of Liver and Biliary Sciences

New Delhi, National Capital Territory of Delhi, 110070, India

Location

MeSH Terms

Conditions

Liver Cirrhosis

Interventions

Nutritional Status; Lactulose; Diet

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Health Status; Demography; Population Characteristics; Disaccharides; Oligosaccharides; Polysaccharides; Carbohydrates; Sugars

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2017
• First Posted: May 19, 2017
• Study Start: May 15, 2017
• Primary Completion: October 1, 2018
• Study Completion: October 1, 2018
• Last Updated: December 11, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)