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 : Recruiting
First Posted : May 19, 2017
Last Update Posted : June 21, 2018
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)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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
Lactulose plus diet consumed by patient
Dietary Supplement: Diet
Protein Powder 15 to 20 gm/meal/day
- Number of patients develop hepatic encephalopathy in both groups [ Time Frame: 6 Months ]
- 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).
- 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
- Time taken for first breakthrough episode of overt hepatic encephalopathy [ Time Frame: 6 Months ]
- Time to first overt hepatic encephalopathy-related hospital admission [ Time Frame: 6 Months ]
- Mortality over 6 months [ Time Frame: 6 Months ]
- Changes in serum cytokines (IL-1,6,10,18,TNF,Endotoxins,myostatin levels) [ Time Frame: 6 Months ]
- Changes in Stool microbiota for 20 patients [ Time Frame: 6 Months ]
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
|Contact: Dr Harsh Tevethia, MDfirstname.lastname@example.org|
|Institute of Liver and Biliary Sciences||Recruiting|
|New Delhi, Delhi, India, 110070|