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

• Status: Completed
• Trial end date: 2012-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: CD Pharma India Pvt. Ltd.
• Collaborators: All India Institute of Medical Sciences, New Delhi; Indian Council of Medical Research
• Treatments: Lactulose

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