Pilot Open-Label Trial of Resistant Potato Starch in Patients With Cirrhosis and Overt Hepatic Encephalopathy
Mayo Clinic
Summary
This research is studying how a food product (resistant potato starch) which is a dietary supplement made from potato starch affects the gut bacteria of people with cirrhosis and hepatic encephalopathy. The researchers in this study want to understand how potato starch works in the subject's body and how the body will react to it. Along with taking the study product participants health-related information and stool will be collected for this research study.
Eligibility
- Age range
- 18–99 years
- Sex
- All
- Healthy volunteers
- No
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-effe…
Interventions
- OtherResistant Potato Starch
Participants will receive 4 weeks of resistant potato starch 20 grams (g) twice daily. Bob's Red Mill® potato starch will be used. Every patient will receive the same dose and there are no dose titrations.
Locations (2)
- Mayo ClinicRochester, Minnesota
- Mayo ClinicRochester, Minnesota