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
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying how resistant potato starch, a dietary supplement made from potato starch, affects gut bacteria in people with cirrhosis and overt hepatic encephalopathy. The study aims to understand how this supplement works in the body and how the body responds to it. This research is led by Mayo Clinic and focuses on improving knowledge about gut health in this group of patients. Participants will take 20 grams of resistant potato starch twice daily for four weeks using Bob's Red Mill ae potato starch. There is no dose adjustment; all participants receive the same amount. This is an open-label trial, meaning both participants and researchers know the treatment being given. During the study, participants will provide health information and stool samples. Researchers will measure changes in stool short-chain fatty acids, cognitive function through an animal naming test, gastrointestinal symptoms, and record any adverse events. The study will track adherence to the supplement and feasibility of completing study activities over eight weeks, with particular focus on changes from baseline to week four.
CONDITIONS
Brief 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 available for the study duration
- Diagnosis of cirrhosis by liver biopsy, imaging, or clinical decompensation evidence
- History of at least one overt hepatic encephalopathy episode in the last year, defined by West Haven Criteria Grades II to IV
- Sexually active women of childbearing potential must use highly effective contraception 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 within the last 4 weeks (rifaximin allowed)
- Planned antibiotic use in the next 4 weeks
- Use of lactulose within the last 4 weeks
- Alcohol or illicit drug use within the last 4 weeks, defined as more than 1 alcoholic drink per week
- History of inflammatory bowel disease
- History of primary sclerosing cholangitis
- Total bilirubin over 4 mg/dL in the last 3 months
- Prior diagnosis of dementia or other primary neurocognitive disorder
- Pregnant or breastfeeding
- Placement of portosystemic shunt or transjugular intrahepatic portosystemic shunt within the last 3 months
- Allergy to resistant potato starch
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 weeks
Participants receive resistant potato starch 20 grams twice daily for 4 weeks.
Visits at baseline and Week 4
Duration - 4 weeks
Participants are monitored for safety and study outcomes after treatment ends.
Visits up to Week 8
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
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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