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

NCT01008293 | Completed Phase 2

• 1 other identifier: MHE-VSL3-YKJ_AIIMS_ver1
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Liver Disease; Hepatic Encephalopathy

Outcome Measures

Primary Outcomes (1)

• 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

  2 months

Study Arms (2)

VSL#3

EXPERIMENTAL

Drug: VSL#3

Lactulose

ACTIVE COMPARATOR

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

Drug: Lactulose

Interventions

VSL#3 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)

VSL#3

Lactulose DRUG

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

Also known as: Duphalac

Lactulose

Eligibility Criteria

• Age: 15 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• CD Pharma India Pvt. Ltd.: lead
• Indian Council of Medical Research: collaborator
• All India Institute of Medical Sciences: collaborator

Study Sites (1)

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

New Delhi, National Capital Territory of Delhi, 110029, India

Location

MeSH Terms

Conditions

Hepatic Encephalopathy

Interventions

Lactulose

Condition Hierarchy (Ancestors)

Liver Failure; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases; Brain Diseases, Metabolic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Disaccharides; Oligosaccharides; Polysaccharides; Carbohydrates; Sugars

Study Officials

• Y K Joshi, Prof.

  All India Institute of Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2009
• First Posted: November 5, 2009
• Study Start: October 1, 2009
• Primary Completion: June 1, 2012
• Study Completion: October 1, 2012
• Last Updated: June 4, 2013

Record last verified: 2013-06

Locations

IN (1)