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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nutrional Therapy Group | Experimental | Nutritional group- Protein of 1.5 gm/kg thrice daily for 6 months |
|
| Lactulose Group | Active Comparator | Lactulose - 20 mL thrice daily (maximum) for 6 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nutrition | Dietary Supplement | Nutrional group-30 kcal/kg with 1.5 grm protein with protein supplements |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients develop hepatic encephalopathy in both groups | 6 Months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Liver and Biliary Sciences | New Delhi | National Capital Territory of Delhi | 110070 | India |
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| Lactulose | Drug | Lactulose plus diet consumed by patient |
|
| Diet | Dietary Supplement | Protein Powder 15 to 20 gm/meal/day |
|
Improvement will be measured by dexa scan , C T scan and by measuring mid arm circumference, triceps skin fold thickness, hand grip |
| 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 |
| Changes in serum cytokines (IL-1,6,10,18,TNF,Endotoxins,myostatin levels) | 6 Months |
| Changes in Stool microbiota for 20 patients | 6 Months |
| ID | Term |
|---|---|
| D008103 | Liver Cirrhosis |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D009752 | Nutritional Status |
| D007792 | Lactulose |
| D004032 | Diet |
| ID | Term |
|---|---|
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D006304 | Health Status |
| D003710 | Demography |
| D011154 | Population Characteristics |
| D004187 | Disaccharides |
| D009844 | Oligosaccharides |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D000073893 | Sugars |
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