Secondary Prophylaxis of Hepatic Encephalopathy in Cirrhosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2010-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Hepatic Encephalopathy

Study Groups

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lactulose

will receive 30-60 ml of lactulose in 2 or 3 divided doses so that patient passed 2-3 semisoft stools per day

Group Type ACTIVE_COMPARATOR

Lactulose

Intervention Type DRUG

will receive 30-60 ml of lactulose in 2 or 3 divided doses so that patient passed 2-3 semisoft stools per day

probiotics

Group Type ACTIVE_COMPARATOR

Probiotics(VSL#3)

Intervention Type DRUG

will receive VSL#3 (110 billion CFU)three times a day

Interventions

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Lactulose

will receive 30-60 ml of lactulose in 2 or 3 divided doses so that patient passed 2-3 semisoft stools per day

Intervention Type DRUG

Probiotics(VSL#3)

will receive VSL#3 (110 billion CFU)three times a day

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No