Secondary Prophylaxis of Hepatic Encephalopathy in Cirrhosis (HE)

Govind Ballabh Pant Hospital

Status and phase

Unknown

Phase 4

Conditions

Hepatic Encephalopathy

Treatments

Drug: Probiotics(VSL#3)

Drug: Lactulose

Study type

Interventional

Funder types

Other

Identifiers

NCT01178372

PS002

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.