Secondary Prophylaxis of Hepatic Encephalopathy in Cirrhosis

Hepatic Encephalopathy Clinical Trial

— HE  

Official title:

Secondary Prophylaxis of Hepatic Encephalopathy in Cirrhosis: An Open Label, Randomized Controlled Trial of Lactulose, Probiotics and No-therapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01178372
• Other study ID #: PS002
• Status: Recruiting
• Phase: Phase 4
• First received: August 9, 2010
• Last updated: August 9, 2010
• Start date: September 2008
• Est. completion date: September 2010

Study information

• Verified date: September 2009
• Source: Govind Ballabh Pant Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 0
• Est. completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

N/A

Related Conditions & MeSH terms

• Brain Diseases
• Hepatic Encephalopathy

Intervention

Drug:
• Lactulose
will receive 30-60 ml of lactulose in 2 or 3 divided doses so that patient passed 2-3 semisoft stools per day
• Probiotics(VSL#3)
will receive VSL#3 (110 billion CFU)three times a day

Locations

Country	Name	City	State
India	G B Pant Hospital	New Delhi	Delhi

Sponsors (1)

Lead Sponsor	Collaborator
Govind Ballabh Pant Hospital

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	episode of overt hepatic encephalopathy		6 months	Yes
Secondary	side effects to therapy		6 months	Yes