Effect of Probiotics in Treatment of Minimal Hepatic Encephalopathy (MHE) and Health Related Quality of Life
Condition: Chronic Liver Disease; Hepatic Encephalopathy
MeSH terms: Liver Diseases; Hepatic Encephalopathy; Brain Diseases
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): VSL#3; Lactulose
Intervention type(s): Drug; Drug
Intervention description(s): 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); 30-60 ml of lactulose per day for 2 months to ensure 2-3 soft stools.
Other intervention name(s): Duphalac
Intervention MeSH terms: Lactulose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment