Effect of Probiotics in Treatment of Minimal Hepatic Encephalopathy (MHE) and Health Related Quality of Life

NCT ID: NCT01008293

Last Updated: 2013-06-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-10-31
• Study Completion Date: 2012-10-31

Brief 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.

Conditions

Chronic Liver Disease; Hepatic Encephalopathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

VSL#3

Group Type: EXPERIMENTAL

VSL#3

Intervention Type: DRUG

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)

Lactulose

30-60 ml of lactulose per day (2 months) to ensure 2-3 soft stools

Group Type: ACTIVE_COMPARATOR

Lactulose

Intervention Type: DRUG

30-60 ml of lactulose per day for 2 months to ensure 2-3 soft stools.

Interventions

VSL#3

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)

Intervention Type: DRUG

Lactulose

30-60 ml of lactulose per day for 2 months to ensure 2-3 soft stools.

Intervention Type: DRUG

Other Intervention Names

Duphalac

Eligibility Criteria

Inclusion Criteria

• All the patients with Chronic Liver Disease or Minimal Hepatic Encephalopathy (without overt hepatic encephalopathy) aged between 15 to 80 years of both the genders would be enrolled consecutively.

Exclusion Criteria

• Patients with overt hepatic encephalopathy
• Active medical co-morbidities like CHD, chronic respiratory disease, chronic renal disease, malignancies, diabetes etc
• Malignancy
• History of taking lactulose or probiotics or antibiotics, in the past 6 weeks
• Presence of other neurological or psychiatric disorder
• Patients who underwent shunt surgery for portal hypertension
• History of taking medicines likely to interfere with psychometric performance
• History of GI hemorrhage or spontaneous bacterial peritonitis during the past 6 weeks
• Presence of mature cataracts and diabetic retinopathy
• Refused to participate in the study

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Indian Council of Medical Research

OTHER_GOV

Sponsor Role: collaborator

All India Institute of Medical Sciences

OTHER

Sponsor Role: collaborator

CD Pharma India Pvt. Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Y K Joshi, Prof.

Role: PRINCIPAL_INVESTIGATOR

All India Institute of Medical Sciences

Locations

Dept. of Gastroenterology and H.N.U., All India Institute of Medical Sciences

New Delhi, National Capital Territory of Delhi, India

Countries

India

Other Identifiers

MHE-VSL3-YKJ_AIIMS_ver1

Identifier Type: -

Identifier Source: org_study_id