Secondary Prophylaxis of Hepatic Encephalopathy in Cirrhosis (HE)
Primary Purpose
Hepatic Encephalopathy
Status
Unknown status
Phase
Phase 4
Locations
India
Study Type
Interventional
Intervention
Lactulose
Probiotics(VSL#3)
Sponsored by
About this trial
This is an interventional trial for Hepatic Encephalopathy focused on measuring hepatic encephalopathy, lactulose, probiotics
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.
Sites / Locations
- G B Pant HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
lactulose
probiotics
Arm Description
will receive 30-60 ml of lactulose in 2 or 3 divided doses so that patient passed 2-3 semisoft stools per day
Outcomes
Primary Outcome Measures
episode of overt hepatic encephalopathy
Secondary Outcome Measures
side effects to therapy
Full Information
NCT ID
NCT01178372
First Posted
August 9, 2010
Last Updated
August 9, 2010
Sponsor
Govind Ballabh Pant Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01178372
Brief Title
Secondary Prophylaxis of Hepatic Encephalopathy in Cirrhosis
Acronym
HE
Official Title
Secondary Prophylaxis of Hepatic Encephalopathy in Cirrhosis: An Open Label, Randomized Controlled Trial of Lactulose, Probiotics and No-therapy
Study Type
Interventional
2. Study Status
Record Verification Date
September 2009
Overall Recruitment Status
Unknown status
Study Start Date
September 2008 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2010 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Govind Ballabh Pant Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatic Encephalopathy
Keywords
hepatic encephalopathy, lactulose, probiotics
7. Study Design
Study Phase
Phase 4
8. Arms, Groups, and Interventions
Arm Title
lactulose
Arm Type
Active Comparator
Arm Description
will receive 30-60 ml of lactulose in 2 or 3 divided doses so that patient passed 2-3 semisoft stools per day
Arm Title
probiotics
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Lactulose
Intervention Description
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
Intervention Name(s)
Probiotics(VSL#3)
Intervention Description
will receive VSL#3 (110 billion CFU)three times a day
Primary Outcome Measure Information:
Title
episode of overt hepatic encephalopathy
Time Frame
6 months
Secondary Outcome Measure Information:
Title
side effects to therapy
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barjesh C Sharma, MD,DM
Organizational Affiliation
G B Pant Hospital New Delhi 110002
Official's Role
Principal Investigator
Facility Information:
Facility Name
G B Pant Hospital
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110002
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Barjesh C Sharma, MD,DM
Phone
9718599203
Email
drbcsharma@hotmail.com
First Name & Middle Initial & Last Name & Degree
Barjesh C Sharma, MD,DM
12. IPD Sharing Statement
Learn more about this trial
Secondary Prophylaxis of Hepatic Encephalopathy in Cirrhosis
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