Pilot Open-Label Trial of Resistant Potato Starch in Patients With Cirrhosis and Overt Hepatic Encephalopathy

Inclusion Criteria:

• Able to provide consent, with signed and dated informed consent form.

• Stated willingness to comply with all study procedures and availability for theduration of the study.

• Diagnosis of cirrhosis based on liver biopsy, imaging, or evidence of clinicaldecompensation.

• History of at least one episode of overt Hepatic Encephalopathy (HE) in the lastyear.

• Defined by West Haven Criteria Grades II to IV

• Can be precipitated Hepatic Encephalopathy (HE) episode.

• Sexually active women of childbearing potential enrolled in the study must agree touse a highly-effective method of contraception (defined in the protocol) for theduration of the study.

Exclusion Criteria:

• Hospitalization in the last 4 weeks

• Current refractory ascites (requiring large volume paracentesis to manage ascites)

• Gut-absorbable or intravenous antibiotic therapy in the last 4 weeks (rifaximin ispermitted)

• Anticipated antibiotics in the coming 4 weeks

• Use of lactulose in the last 4 weeks

• Alcohol or illicit drug intake in the last 4 weeks

• By history

• Alcohol use will be characterized as >1 alcoholic drink / week

• History of inflammatory bowel disease

• History of primary sclerosing cholangitis

• Total bilirubin in the last 3 months > 4 mg/dL

• Prior diagnosis of dementia or other primary neurocognitive disorder

• Pregnancy or breast feeding

• Placement of a portosystemic shunt or transjugular intrahepatic portosystemic shuntin the last 3 months (permissible if placed >3 months before enrollment)

• Allergy to resistant potato starch