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

Liver Cirrhosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03161106
• Other study ID #: ILBS-Cirrhosis-12
• Status: Withdrawn
• Phase: N/A
• Start date: May 15, 2017
• Est. completion date: October 1, 2018

Study information

• Verified date: June 2018
• Source: Institute of Liver and Biliary Sciences, India
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 1, 2018
• Est. primary completion date: October 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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).

Related Conditions & MeSH terms

• Brain Diseases
• Fibrosis
• Hepatic Encephalopathy
• Liver Cirrhosis

Intervention

Dietary Supplement:
• Nutrition
Nutrional group-30 kcal/kg with 1.5 grm protein with protein supplements

Drug:
• Lactulose
Lactulose plus diet consumed by patient

Dietary Supplement:
• Diet
Protein Powder 15 to 20 gm/meal/day

Locations

Country	Name	City	State
India	Institute of Liver and Biliary Sciences	New Delhi	Delhi

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Liver and Biliary Sciences, India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients develop hepatic encephalopathy in both groups		6 Months
Secondary	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
Secondary	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
Secondary	Time taken for first breakthrough episode of overt hepatic encephalopathy		6 Months
Secondary	Time to first overt hepatic encephalopathy-related hospital admission		6 Months
Secondary	Mortality over 6 months		6 Months
Secondary	Changes in serum cytokines (IL-1,6,10,18,TNF,Endotoxins,myostatin levels)		6 Months
Secondary	Changes in Stool microbiota for 20 patients		6 Months