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

• Sponsor: Institute of Liver and Biliary Sciences, India (Other)
• Overall Status: Withdrawn
• CT.gov ID: NCT03161106
• Collaborator: (none)
• Enrollment: 0
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 16.6
• Patients Per Site Per Month: 0

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Liver Cirrhosis	Dietary Supplement: Nutrition; Drug: Lactulose; Dietary Supplement: Diet	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 0 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: May 15, 2017
• Anticipated Primary Completion Date: Oct 1, 2018
• Anticipated Study Completion Date: Oct 1, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Number of patients develop hepatic encephalopathy in both groups [6 Months]

Secondary Outcome Measures

1. Improvement in health related quality of life over 6 months [6 Months]

   Improvement will be defined on the basis of HRQOL (Health Related Quality of Life Index).

2. 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]

   Improvement will be measured by dexa scan , C T scan and by measuring mid arm circumference, triceps skin fold thickness, hand grip

3. Time taken for first breakthrough episode of overt hepatic encephalopathy [6 Months]

4. Time to first overt hepatic encephalopathy-related hospital admission [6 Months]

5. Mortality over 6 months [6 Months]

6. Changes in serum cytokines (IL-1,6,10,18,TNF,Endotoxins,myostatin levels) [6 Months]

7. Changes in Stool microbiota for 20 patients [6 Months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Institute of Liver and Biliary Sciences	New Delhi	Delhi	India	110070

Sponsors and Collaborators

• Institute of Liver and Biliary Sciences, India

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Institute of Liver and Biliary Sciences, India
• ClinicalTrials.gov Identifier: NCT03161106
• Other Study ID Numbers: ILBS-Cirrhosis-12
• First Posted: May 19, 2017
• Last Update Posted: Dec 11, 2018
• Last Verified: Jun 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Liver Cirrhosis; Hepatic Encephalopathy; Brain Diseases; Fibrosis; Lactulose

Study Results

No Results Posted as of Dec 11, 2018