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Health Related Quality of Life in Patient With Chronic Liver Disease and Effect of Probiotics in the Treatment of MHE and Health Related Quality of Life
This study is a randomized, open, parallel group, active comparator, single center trial. Objectives of the study are hereby given below: * To study the health related quality of life (HRQOL) in patients with chronic liver disease. * To assess the prevalence of minimal hepatic encephalopathy (MHE) in patients with chronic liver disease and assessment of HRQOL in patients with MHE. * To compare the effect of probiotics and lactulose in the treatment of MHE * To assess the effect of probiotics and lactulose on the HRQOL in patients with MHE.
The study design would comprise of two parts 1. Part I: Cross sectional study: This part would comprise of the assessment of HRQOL in patients with CLD 1. All the consecutive patients diagnosed as CLD would be enrolled in the study. All these patients would be enrolled from the liver clinics of the department of gastroenterology and those admitted in the gastroenterology ward at AIIMS. 2. Alcohol would be considered to be the cause of CLD, if the patient regularly consumed ≥80g/d of alcohol for five years 3. The staging of cirrhosis would be done according to the Child Pugh classification: A, B and C 4. The causes of CLD would be divided into:- viral hepatitis, alcohol, viral hepatitis combining with alcohol and miscellaneous causes 2. Part II: Prospective randomized controlled trial: In this part the outcome of lactulose and probiotic therapy in the treatment of MHE and its effect on the HRQOL will be compared. 1. All the consecutive patients with CLD without overt encephalopathy would be screened for MHE. 2. All these patients would be enrolled from the liver clinics and the gastroenterology ward, AIIMS. 3. The diagnosis of MHE would be based on abnormal psychometric tests (NCT-A and NCT-B or FCT-A and FCT-B) and /or abnormal P300 auditory event related potentials.
Age
15 - 80 years
Sex
ALL
Healthy Volunteers
No
Dept. of Gastroenterology and H.N.U., All India Institute of Medical Sciences
New Delhi, National Capital Territory of Delhi, India
Start Date
October 1, 2009
Primary Completion Date
June 1, 2012
Completion Date
October 1, 2012
Last Updated
June 4, 2013
120
ACTUAL participants
VSL#3
DRUG
Lactulose
DRUG
Lead Sponsor
CD Pharma India Pvt. Ltd.
Collaborators
NCT07480057
NCT06181409
NCT06449339
Data Source & Attribution
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