Secondary Prophylaxis of Hepatic Encephalopathy With a Probiotic Preparation

• Status: Completed
• Trial end date: 2013-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The aim of the proposed project is to study the effects of a probiotic preparation (VSL#3®) for the prevention of recurrence of HE (Hepatic encephalopathy) in patients after the recovery of an episode of overt HE (secondary prophylaxis)

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

Details

• Lead Sponsor: CD Pharma India Pvt. Ltd.
• Collaborator: Postgraduate Institute of Medical Education and Research

Criteria

Inclusion Criteria:

• Patients diagnosed as having cirrhosis of liver at the Inpatient/Outpatient Liver Clinic of Department of Hepatology, PGIMER, Chandigarh, will be candidates for enrollment.

• The diagnosis of cirrhosis of liver will be based on clinical, biochemical, and ultrasonographical or liver histological data.

Exclusion Criteria:

• Alcohol intake during the past 6 weeks

• Hepatocellular carcinoma

• Previous transjugular intrahepatic portosystemic shunt or shunt surgery

• Significant comorbid illness such as heart, respiratory, or renal failure

• Any neurologic diseases such as Alzheimer's disease, Parkinson's disease, and nonhepatic metabolic encephalopathies.

• Patients on psychoactive drugs, such as antidepressants or sedatives

• Those who restart alcohol consumption during follow-up will also be excluded.