Fecal Transplant for Hepatic Encephalopathy

A Prospective Single Center Open Label Trial of RBX2660 (Microbiota Suspension) in the Management of Hepatic Encephalopathy

The purpose of the study is to determine if fecal microbiota transplant (FMT) can reverse hepatic encephalopathy (HE) in cirrhotic patients who continue to have breakthrough episodes of HE despite maintenance therapy with lactulose and/or rifaximin or metronidazole.

Subjects receive FMT from a single donor by colonoscopy at week 0 and by enema at weeks 1-4. HE is measured by Inhibitory Control Test (ICT) and Stroop test as well as fasting serum ammonia levels.

Inclusion Criteria:

• Adult cirrhotic patients of various etiology on lactulose and/pr rifaximin or metronidazole for minimum 4 weeks as secondary prophylaxis
• Abnormal ICT (>5 lures) or abnormal Stroop test (>200 seconds)
• Baseline Conn score 0 or 1
• Infectious etiology of HE has been ruled out

Exclusion Criteria:

• those with tense ascites
• those who do not provide assent
• life expectancy <3 months
• TIPS within the past 3 months
• neurologic disease such as dementia, Parkinson's, structural brain lesions
• pregnancy
• intestinal obstruction
• alcoholic hepatitis
• active alcohol or substance abuse
• those without stable social support
• concurrent infection such as spontaneous bacterial peritonitis, pneumonia or urinary tract infection
• creatinine clearance less that 50% compared to baseline
• hospital admission for HE within one month of enrollment
• active hepatocellular carcinoma
• active GI bleed