Secondary Prophylaxis of Hepatic Encephalopathy in Cirrhosis (HE)
Recruitment status was Recruiting
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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 |
- episode of overt hepatic encephalopathy [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
- 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 |
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| 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 | |
| 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 Fibrosis Brain Damage, Chronic Delirium Encephalitis Neurotoxicity Syndromes Liver Failure Hepatic Insufficiency Liver Diseases Digestive System Diseases Brain Diseases, Metabolic Brain Diseases Central Nervous System Diseases Nervous System Diseases Metabolic Diseases |
Pathologic Processes Confusion Neurobehavioral Manifestations Neurologic Manifestations Signs and Symptoms Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Central Nervous System Viral Diseases Virus Diseases Central Nervous System Infections Poisoning Substance-Related Disorders Lactulose Gastrointestinal Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 19, 2013