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

This study has been completed.
Sponsor:
Collaborators:
Indian Council of Medical Research
All India Institute of Medical Sciences, New Delhi
Information provided by (Responsible Party):
CD Pharma India Pvt. Ltd.
ClinicalTrials.gov Identifier:
NCT01008293
First received: November 4, 2009
Last updated: June 3, 2013
Last verified: June 2013
  Purpose

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.

Condition Intervention Phase
Chronic Liver Disease
Hepatic Encephalopathy
Drug: VSL#3
Drug: Lactulose
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
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

Resource links provided by NLM:


Further study details as provided by CD Pharma India Pvt. Ltd.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 120
Study Start Date: October 2009
Study Completion Date: October 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: VSL#3 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)
Other Name: VSL#3
Active Comparator: Lactulose
30-60 ml of lactulose per day (2 months) to ensure 2-3 soft stools
Drug: Lactulose
30-60 ml of lactulose per day for 2 months to ensure 2-3 soft stools.
Other Name: Duphalac

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.
  Eligibility

Ages Eligible for Study:   15 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01008293

Locations
India
Dept. of Gastroenterology and H.N.U., All India Institute of Medical Sciences
New Delhi, Delhi, India, 110029
Sponsors and Collaborators
CD Pharma India Pvt. Ltd.
Indian Council of Medical Research
All India Institute of Medical Sciences, New Delhi
Investigators
Principal Investigator: Y K Joshi, Prof. All India Institute of Medical Sciences, New Delhi
  More Information

No publications provided

Responsible Party: CD Pharma India Pvt. Ltd.
ClinicalTrials.gov Identifier: NCT01008293     History of Changes
Other Study ID Numbers: MHE-VSL3-YKJ_AIIMS_ver1
Study First Received: November 4, 2009
Last Updated: June 3, 2013
Health Authority: India: Drugs Controller General of India
India: Indian Council of Medical Research

Additional relevant MeSH terms:
Liver Diseases
Brain Diseases
Hepatic Encephalopathy
Digestive System Diseases
Central Nervous System Diseases
Nervous System Diseases
Liver Failure
Hepatic Insufficiency
Brain Diseases, Metabolic
Metabolic Diseases
Lactulose
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 22, 2014