Using resistant potato starch to treat cirrhosis and hepatic encephalopathy
Pilot Open-Label Trial of Resistant Potato Starch in Patients With Cirrhosis and Overt Hepatic Encephalopathy
This study is testing if eating resistant potato starch can help improve gut health and symptoms in people with cirrhosis and hepatic encephalopathy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 11 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 2 sites (Rochester, Minnesota and 1 other locations) |
| Trial ID | NCT06425380 on ClinicalTrials.gov |
What this trial studies
This research investigates the effects of resistant potato starch, a dietary supplement, on gut bacteria in patients with cirrhosis and overt hepatic encephalopathy. Participants will consume the supplement while their health-related information and stool samples are collected to assess the body's response. The study aims to understand how this food product may influence the condition and overall gut health of individuals suffering from these liver-related issues.
Who should consider this trial
Good fit: Ideal candidates are individuals diagnosed with cirrhosis and who have experienced at least one episode of overt hepatic encephalopathy in the past year.
Not a fit: Patients who have been hospitalized in the last four weeks or are currently experiencing refractory ascites may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a novel dietary intervention to improve gut health and manage symptoms in patients with cirrhosis and hepatic encephalopathy.
How similar studies have performed: While the use of dietary supplements in liver disease is an emerging area, this specific approach with resistant potato starch is novel and has not been extensively tested in similar studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Rochester, Minnesota and 1 other locations
- Mayo Clinic — Rochester, Minnesota, United States (Recruiting)
- Mayo Clinic — Rochester, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Patricia Bloom, MD — Mayo Clinic
- Study coordinator: Jenny Obst
- Email: obst.jenny@mayo.edu
- Phone: 507-255-1337
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.