Skip to main content
OpenTrials
Completed

NCT Number: NCT01008293

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Chronic Liver Disease Brain Diseases Brain Diseases, Metabolic Central Nervous System Diseases Digestive System Diseases Hepatic Encephalopathy Hepatic Insufficiency Liver Diseases Liver Failure Metabolic Diseases Nervous System Diseases Nutritional and Metabolic Diseases

Age range

15 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

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

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

About this study

The study design would comprise of two parts

  • Part I: Cross sectional study: This part would comprise of the assessment of HRQOL in patients with CLD
  • 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.
  • Alcohol would be considered to be the cause of CLD, if the patient regularly consumed ≥80g/d of alcohol for five years
  • The staging of cirrhosis would be done according to the Child Pugh classification: A, B and C
  • The causes of CLD would be divided into:- viral hepatitis, alcohol, viral hepatitis combining with alcohol and miscellaneous causes
  • 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.
  • All the consecutive patients with CLD without overt encephalopathy would be screened for MHE.
  • All these patients would be enrolled from the liver clinics and the gastroenterology ward, AIIMS.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

Lactulose

Drug

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

Other names: Duphalac

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

    Time frame: 2 months

Sponsors and collaborators

Lead sponsor

CD Pharma India Pvt. Ltd.

Industry

Collaborators

  • All India Institute of Medical Sciences
  • Indian Council of Medical Research

Registry information

Official study 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

Acronym: MHE

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Nov 5, 2009
Registry last updated
Jun 4, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.