Secondary Prophylaxis of Hepatic Encephalopathy in Cirrhosis

Phase 4

• Conditions: Hepatic Encephalopathy
• Interventions: Drug: Probiotics(VSL#3); Drug: Lactulose

• Registration Number: NCT01178372
• Lead Sponsor: Govind Ballabh Pant Hospital

Brief Summary

Hepatic encephalopathy (HE), a challenging complication of advanced liver disease, occurs in approximately 30-45% of patients with cirrhosis. The treatment of choice is non-absorbable disaccharides, such as lactulose and lactitol.Probiotics are effective in the treatment of minimal hepatic encephalopathy which precipitates hepatic encephalopathy. The investigators will assess the effects of lactulose and probiotics for the prevention of recurrence of HE (secondary prophylaxis) in patients after the recovery of an episode of overt hepatic encephalopathy.

Detailed Description

Hepatic encephalopathy, a challenging complication of advanced liver disease, occurs in approximately 30-45% of patients with cirrhosis and 10-50% of patients with transjugular intrahepatic portosystemic shunt.Although the occurrence of episodes of hepatic encephalopathy appears to be unrelated to the cause of cirrhosis,increases in the frequency and severity of such episodes predict an increased risk of death.A small metaanalysis determined that lactulose and lactitol were equally effective in the treatment of HE.Probiotics alter the gut flora resulting in decreased ammonia production and absorption due to decreased intraluminal pH. Also shown to alter the short chain fatty acid production, \& decrease intestinal permeability.Various studies have shown some improvement in either the prevalence of minimal hepatic encephalopathy or results in neuropsychological tests with the use of probiotics.Lactulose and probiotics improves minimal hepatic encephalopathy in cirrhotic patients and it has also been shown that minimal hepatic encephalopathy predisposes the cirrhotic patient to HE.We will assess the effects of lactulose and probiotics for the prevention of recurrence of hepatic encephalopathy (secondary prophylaxis) in patients after the recovery of an episode of overt hepatic encephalopathy.

Study Timeline

• Study Start: 2008-09
• Status Verified: 2009-09
• Study First Submitted: 2010-08-09
• Study First Submitted QC: 2010-08-09
• Last Update Submitted: 2010-08-09
• Study First Posted: 2010-08-10
• Last Update Posted: 2010-08-10
• Study Completion: 2010-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Patients with cirrhosis and previous history of recovery from hepatic encephalopathy

Exclusion Criteria

• history of taking lactulose in the past 6 weeks.
• alcohol intake during the past 6 weeks or during follow up
• patients on secondary prophylaxis for spontaneous bacterial peritonitis
• previous TIPS 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
probiotics	Probiotics(VSL#3)	-
lactulose	Lactulose	will receive 30-60 ml of lactulose in 2 or 3 divided doses so that patient passed 2-3 semisoft stools per day

Primary Outcome Measures

Name	Time	Method
episode of overt hepatic encephalopathy	6 months

Secondary Outcome Measures

Name	Time	Method
side effects to therapy	6 months

Trial Locations

Locations (1)

G B Pant Hospital; 🇮🇳 New Delhi, Delhi, India