Secondary Prophylaxis of Hepatic Encephalopathy With a Probiotic Preparation
Secondary Prophylaxis of Hepatic Encephalopathy With a Probiotic Preparation
The aim of the proposed project is to study the effects of a probiotic preparation (VSL#3®)
 for the prevention of recurrence of HE (Hepatic encephalopathy) in patients after the
 recovery of an episode of overt HE (secondary prophylaxis)
Hepatic encephalopathy (HE) represents a spectrum of neuropsychiatric abnormalities seen in
 patients with liver dysfunction after exclusion of other known brain disease. The Working
 Party at the 11th World Congress of Gastroenterology, Vienna proposed a multi-axial
 definition of HE that defined both, the type of hepatic abnormality (type A, B or C) and the
 duration/characteristics of neurological manifestations (episodic, persistent or minimal HE)
 in chronic liver disease. Overt hepatic encephalopathy occurs in 30%-45% of cirrhotic
 patients and 10%-50% of patients with transjugular intrahepatic portosystemic shunt.
 Development of HE is associated with a poor prognosis. Bustamante et al reported the survival
 probability of 42% at 1 year of follow-up and 23% at 3 years in patients with cirrhosis with
 a first episode of acute HE. The primary treatment of HE is the identification and treatment
 of the precipitating factors. The majority of the drugs used in the treatment of HE are
 primarily directed at the reduction or elimination of the increased neurotoxic ammonia
 levels. A meta-analysis of 22 randomized trials highlighted the lack of data supporting the
 efficacy of nonabsorbable disaccharides; however, the investigators concluded that current
 evidence is insufficient to support or refute the use of nonabsorbable disaccharides for
 treatment of HE. Recent studies with well defined groups however demonstrated the efficacy of
 lactulose. Alternative therapies such as benzodiazepine receptor antagonists, branched-chain
 amino acids, and L-ornithine-L-aspartate also have been shown to have some role. Antibiotics
 are effective in the treatment of HE, but adverse effects and concerns about long-term safety
 have limited their widespread use. Probiotics may have multiple beneficial effects in the
 prevention and/or treatment of HE. All four published studies on the effect of probiotics on
 hepatic encephalopathy have demonstrated efficacy. Treating patients to prevent development
 of a first episode is classified as primary prophylaxis of HE and preventing recurrence of HE
 in patients who had a previous episode of HE as secondary prophylaxis of HE. Sharma et al
 recently demonstrated that lactulose is effective in secondary prevention of HE. This study
 will assess the effects of a probiotic preparation for the prevention of recurrence of HE
 (secondary prophylaxis) in patients after the recovery of an episode of overt HE.
Inclusion Criteria:

 -  Patients diagnosed as having cirrhosis of liver at the Inpatient/Outpatient Liver
 Clinic of Department of Hepatology, PGIMER, Chandigarh, will be candidates for
 enrollment.

 -  The diagnosis of cirrhosis of liver will be based on clinical, biochemical, and
 ultrasonographical or liver histological data.

 Exclusion Criteria:

 -  Alcohol intake during the past 6 weeks

 -  Hepatocellular carcinoma

 -  Previous transjugular intrahepatic portosystemic shunt 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.

 -  Patients on psychoactive drugs, such as antidepressants or sedatives

 -  Those who restart alcohol consumption during follow-up will also be excluded.