Actively Recruiting
Pilot Open-Label Trial of Resistant Potato Starch in Patients With Cirrhosis and Overt Hepatic Encephalopathy
Led by Mayo Clinic · Updated on 2026-01-30
11
Participants Needed
2
Research Sites
132 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Pilot Open-Label Trial of Resistant Potato Starch in Patients With Cirrhosis and Overt Hepatic Encephalopathy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to provide signed and dated informed consent.
- Willing to comply with all study procedures and be available for the study duration.
- Diagnosis of cirrhosis confirmed by liver biopsy, imaging, or clinical decompensation.
- History of at least one overt Hepatic Encephalopathy episode in the last year (West Haven Grades II to IV), including precipitated episodes.
- Sexually active women of childbearing potential must agree to use a highly-effective contraception method during the study.
You will not qualify if you...
- Hospitalization within the last 4 weeks.
- Current refractory ascites requiring large volume paracentesis.
- Use of gut-absorbable or intravenous antibiotics in the last 4 weeks (except rifaximin).
- Planned antibiotic use in the next 4 weeks.
- Use of lactulose in the last 4 weeks.
- Alcohol or illicit drug use in the last 4 weeks (more than 1 alcoholic drink per week).
- History of inflammatory bowel disease.
- History of primary sclerosing cholangitis.
- Total bilirubin > 4 mg/dL in the last 3 months.
- Prior diagnosis of dementia or other primary neurocognitive disorder.
- Pregnancy or breastfeeding.
- Portosystemic shunt or transjugular intrahepatic portosystemic shunt placed within the last 3 months.
- Allergy to resistant potato starch.
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Mayo Clinic
Rochester, Minnesota, United States, 55902
Actively Recruiting
2
Mayo Clinic
Rochester, Minnesota, United States, 55905
Actively Recruiting
Research Team
J
Jenny Obst
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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