VE303 for Treatment of Hepatic Encephalopathy (HE)

Inclusion criteria

• Diagnosis of cirrhosis based on liver biopsy, imaging, or evidence of clinical decompensation
• History of at least one episode of overt HE any time in the past
• Prescribed both lactulose and rifaximin, and compliant with this treatment

Exclusion criteria

• Current episode of overt HE
• Variceal bleeding in the last 4 weeks
• Gut-absorbable or intravenous antibiotic therapy in the last 28 days
• Fecal microbiota transplant in the last 6 months
• Use of probiotics in the last 2 weeks
• Alcohol or illicit drug intake in the last 4 weeks
• Primary sclerosing cholangitis as etiology of liver disease
• History of inflammatory bowel disease, short gut, gastrointestinal tract fistulas, intestinal ischemia, or any form of ongoing colitis
• Prior diagnosis of dementia or other primary neurocognitive disorder
• Known hypersensitivity/allergy/intolerance to Vancomycin and any ingredients of VE303: sucrose, histidine, yeast extract, cysteine, metabisulfite, and microcrystalline cellulose
• History of Roux-en-Y Gastric bypass
• Any gastrointestinal surgery in the last year
• Substantial immune compromise/deficiency (e.g., uncontrolled human immunodeficiency virus, active immune suppressive therapy including high doses of corticosteroids or medications to prevent graft rejection, recent myeloablative therapy, sustained neutropenia)
• Pregnancy or breast feeding
• Model for end-stage liver disease (MELD) > 20
• History of spontaneous bacterial peritonitis
• Hemodialysis in the last 28 days
• Placement of a portosystemic shunt or transjugular intrahepatic portosystemic shunt in the last 3 months (permissible if placed >3 months before enrollment)
• Unstable doses of opiates, benzodiazepines or other sedating medication
• Chronic methadone or low dose benzodiazepines (for example) is acceptable