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

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ClinicalTrials.gov Identifier: NCT03161106
Recruitment Status : Withdrawn (due lack of funds)
First Posted : May 19, 2017
Last Update Posted : December 11, 2018
Sponsor:
Information provided by (Responsible Party):
Institute of Liver and Biliary Sciences, India

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 Not Applicable

Study Type : Interventional  (Clinical Trial)
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
Estimated Primary Completion Date : October 1, 2018
Estimated Study Completion Date : October 1, 2018


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




Primary Outcome Measures :
  1. Number of patients develop hepatic encephalopathy in both groups [ Time Frame: 6 Months ]

Secondary Outcome Measures :
  1. Improvement in health related quality of life over 6 months [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 6 Months ]
  4. Time to first overt hepatic encephalopathy-related hospital admission [ Time Frame: 6 Months ]
  5. Mortality over 6 months [ Time Frame: 6 Months ]
  6. Changes in serum cytokines (IL-1,6,10,18,TNF,Endotoxins,myostatin levels) [ Time Frame: 6 Months ]
  7. Changes in Stool microbiota for 20 patients [ Time Frame: 6 Months ]


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03161106


Locations
India
Institute of Liver and Biliary Sciences
New Delhi, Delhi, India, 110070
Sponsors and Collaborators
Institute of Liver and Biliary Sciences, India

Responsible Party: Institute of Liver and Biliary Sciences, India
ClinicalTrials.gov Identifier: NCT03161106     History of Changes
Other Study ID Numbers: ILBS-Cirrhosis-12
First Posted: May 19, 2017    Key Record Dates
Last Update Posted: December 11, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
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
Fibrosis
Brain Diseases
Hepatic Encephalopathy
Pathologic Processes
Liver Diseases
Digestive System Diseases
Central Nervous System Diseases
Nervous System Diseases
Liver Failure
Hepatic Insufficiency
Brain Diseases, Metabolic
Metabolic Diseases
Lactulose
Gastrointestinal Agents