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

NCT ID: NCT03161106

Last Updated: 2018-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-15

Study Completion Date

2018-10-01

Brief Summary

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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.

Detailed Description

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Conditions

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Liver Cirrhosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Nutrional Therapy Group

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

Group Type EXPERIMENTAL

Nutrition

Intervention Type DIETARY_SUPPLEMENT

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

Lactulose Group

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

Group Type ACTIVE_COMPARATOR

Lactulose

Intervention Type DRUG

Lactulose plus diet consumed by patient

Diet

Intervention Type DIETARY_SUPPLEMENT

Protein Powder 15 to 20 gm/meal/day

Interventions

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Nutrition

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

Intervention Type DIETARY_SUPPLEMENT

Lactulose

Lactulose plus diet consumed by patient

Intervention Type DRUG

Diet

Protein Powder 15 to 20 gm/meal/day

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institute of Liver and Biliary Sciences, India

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Institute of Liver and Biliary Sciences

New Delhi, National Capital Territory of Delhi, India

Site Status

Countries

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India

Other Identifiers

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ILBS-Cirrhosis-12

Identifier Type: -

Identifier Source: org_study_id