Effect of Probiotics in Treatment of Minimal Hepatic Encephalopathy (MHE) and Health Related Quality of Life (MHE)
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.
|Chronic Liver Disease Hepatic Encephalopathy||Drug: VSL#3 Drug: Lactulose||Phase 2 Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- To compare the effect of probiotics and lactulose based on normalization of the abnormal test parameters, Neuropsychometric tests, P3ERP, EEG, venous ammonia levels, Development of overt encephalopathy and other complications and HRQOL [ Time Frame: 2 months ]
|Study Start Date:||October 2009|
|Study Completion Date:||October 2012|
|Primary Completion Date:||June 2012 (Final data collection date for primary outcome measure)|
VSL#3 (2 capsules bid.for 2 months, Each containing 112.5 billion viable lyophilized bacteria). Each capsule contains 4 strains of Lactobacillus (L. casei, L. plantarum, L. acidophilus, and L. delbrueckii subsp. bulgaricus), 3 strains of Bifidobacterium (B. longum, L. breve, and B. infantis), and 1 strain of Streptococcus salivarius subsp. thermophilus (designated hereafter as S. thermophilus)
Active Comparator: Lactulose
30-60 ml of lactulose per day (2 months) to ensure 2-3 soft stools
30-60 ml of lactulose per day for 2 months to ensure 2-3 soft stools.
Other Name: Duphalac
The study design would comprise of two parts
Part I: Cross sectional study: This part would comprise of the assessment of HRQOL in patients with CLD
- 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.
- Alcohol would be considered to be the cause of CLD, if the patient regularly consumed ≥80g/d of alcohol for five years
- The staging of cirrhosis would be done according to the Child Pugh classification: A, B and C
- The causes of CLD would be divided into:- viral hepatitis, alcohol, viral hepatitis combining with alcohol and miscellaneous causes
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.
- All the consecutive patients with CLD without overt encephalopathy would be screened for MHE.
- All these patients would be enrolled from the liver clinics and the gastroenterology ward, AIIMS.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01008293
|Dept. of Gastroenterology and H.N.U., All India Institute of Medical Sciences|
|New Delhi, Delhi, India, 110029|
|Principal Investigator:||Y K Joshi, Prof.||All India Institute of Medical Sciences, New Delhi|