Clinical trial NCT01178372: Secondary Prophylaxis of Hepatic Encephalopathy in Cirrhosis
Official title: Secondary Prophylaxis of Hepatic Encephalopathy in Cirrhosis: An Open Label, Randomized Controlled Trial of Lactulose, Probiotics and No-therapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Hepatic Encephalopathy
Keywords: hepatic encephalopathy
lactulose
probiotics
Lead sponsor: Govind Ballabh Pant Hospital
Sponsor class: OTHER_GOV
First posted: 2010-08-10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

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.

Eligibility criteria: 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.

Primary outcomes:
measure: episode of overt hepatic encephalopathy
timeFrame: 6 months
Secondary outcomes:
measure: side effects to therapy
timeFrame: 6 months
Other outcomes:
Locations:
city: New Delhi
country: India
facility: G B Pant Hospital
state: Delhi
Study officials:
affiliation: G B Pant Hospital New Delhi 110002
name: Barjesh C Sharma, MD,DM
role: PRINCIPAL_INVESTIGATOR
References: