Secondary Prophylaxis of Hepatic Encephalopathy in Cirrhosis (HE)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by Govind Ballabh Pant Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Govind Ballabh Pant Hospital
ClinicalTrials.gov Identifier:
NCT01178372
First received: August 9, 2010
Last updated: NA
Last verified: September 2009
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Hepatic Encephalopathy
Drug: Lactulose
Drug: Probiotics(VSL#3)
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Govind Ballabh Pant Hospital:

Primary Outcome Measures:
  • episode of overt hepatic encephalopathy [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • side effects to therapy [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Study Start Date: September 2008
Estimated Study Completion Date: September 2010
Arms Assigned Interventions
Active Comparator: lactulose
will receive 30-60 ml of lactulose in 2 or 3 divided doses so that patient passed 2-3 semisoft stools per day
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
Active Comparator: probiotics Drug: Probiotics(VSL#3)
will receive VSL#3 (110 billion CFU)three times a day

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01178372

Locations
India
G B Pant Hospital Recruiting
New Delhi, Delhi, India, 110002
Contact: Barjesh C Sharma, MD,DM    9718599203    drbcsharma@hotmail.com   
Principal Investigator: Barjesh C Sharma, MD,DM         
Sponsors and Collaborators
Govind Ballabh Pant Hospital
Investigators
Principal Investigator: Barjesh C Sharma, MD,DM G B Pant Hospital New Delhi 110002
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT01178372     History of Changes
Other Study ID Numbers: PS002
Study First Received: August 9, 2010
Last Updated: August 9, 2010
Health Authority: India: Institutional Review Board

Keywords provided by Govind Ballabh Pant Hospital:
hepatic encephalopathy
lactulose
probiotics

Additional relevant MeSH terms:
Hepatic Encephalopathy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Liver Failure
Hepatic Insufficiency
Liver Diseases
Digestive System Diseases
Brain Diseases, Metabolic
Metabolic Diseases
Lactulose
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 16, 2014