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

NCT01008293 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2013-06-04

No results posted yet for this study

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.

Conditions

Interventions

DRUG

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)

DRUG

Lactulose

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

Sponsors & Collaborators

  • Indian Council of Medical Research

    collaborator OTHER_GOV

  • All India Institute of Medical Sciences

    collaborator OTHER

  • CD Pharma India Pvt. Ltd.

    lead INDUSTRY

Principal Investigators

  • Y K Joshi, Prof. · All India Institute of Medical Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
15 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2012-06-30
Completion
2012-10-31

Countries

  • India

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01008293 on ClinicalTrials.gov