Hepatic Encephalopathy Clinical Trial
Official title:
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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