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

Launched by UNIVERSITY OF MICHIGAN · May 17, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating how a dietary supplement made from resistant potato starch affects people with cirrhosis and a condition called hepatic encephalopathy, which can cause confusion and other mental changes. The researchers want to see how this starch impacts gut bacteria and overall health in these patients. The study is currently looking for participants who are between the ages of 65 and 93, have been diagnosed with cirrhosis, and have experienced at least one episode of hepatic encephalopathy in the past year.

Eligible participants will have to provide consent and agree to follow the study procedures. During the trial, they will take the resistant potato starch supplement and provide health information and stool samples for analysis. It’s important to note that certain conditions, like recent hospitalization or the use of specific medications, may exclude individuals from participating. Overall, this study aims to explore a potential new way to help manage the symptoms related to liver disease and improve patients' quality of life.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Able to provide consent, with signed and dated informed consent form.
• • Stated willingness to comply with all study procedures and availability for the duration of the study.
• • Diagnosis of cirrhosis based on liver biopsy, imaging, or evidence of clinical decompensation.
• • History of at least one episode of overt Hepatic Encephalopathy (HE) in the last year.
• • 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 to use a highly-effective method of contraception (defined in the protocol) for the duration 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 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
• • 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