Clinical Trials

Inclusion Criteria:

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

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

• Male or female, aged 18 through 99 years old.

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

• History of at least one episode of overt HE in the last year.

  • Defined by West Haven Criteria Grades II to IV

  • Can be precipitated HE episode.

• Sexually active women of childbearing potential enrolled in the study must agree to use a highly-effective method of contraception (defined in Appendix 1) for the duration of the study.

  Patients choosing the virtual option must have a device with internet connectivity and video/audio capability.

Exclusion Criteria:

• Hospitalization in the last 4 weeks.

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

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

• 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. Any woman of childbearing potential will perform a urine pregnancy test prior to starting the potato starch. Those participating virtually will perform the test at home and show study staff the results of the test. If the pregnancy test is positive, the woman will not be entered into the study.

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

• Allergy to resistant potato starch.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 8/1/2025. Questions regarding updates should be directed to the study team contact.