Secondary Prophylaxis of Hepatic Encephalopathy in Cirrhosis
Information source: Govind Ballabh Pant Hospital
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hepatic Encephalopathy
Intervention: Lactulose (Drug); Probiotics(VSL#3) (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Govind Ballabh Pant Hospital Official(s) and/or principal investigator(s):
Barjesh C Sharma, MD,DM, Principal Investigator, Affiliation: G B Pant Hospital New Delhi 110002
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.
Clinical Details
Official title: Secondary Prophylaxis of Hepatic Encephalopathy in Cirrhosis: An Open Label, Randomized Controlled Trial of Lactulose, Probiotics and No-therapy
Study design: N/A
Primary outcome: episode of overt hepatic encephalopathy
Secondary outcome: side effects to therapy
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
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
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.
Locations and Contacts
G B Pant Hospital, New Delhi, Delhi 110002, India; Recruiting
Barjesh C Sharma, MD,DM, Phone: 9718599203, Email: drbcsharma@hotmail.com
Barjesh C Sharma, MD,DM, Principal Investigator
Additional Information
Starting date: September 2008
Last updated: August 9, 2010
|
