NCT06425380 · Mayo Clinic
Pilot Open-Label Trial of Resistant Potato Starch in Patients With Cirrhosis and Overt Hepatic Encephalopathy
What this study 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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- 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
- Rochester, Minnesota
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 30, 2026 · Source of record for eligibility and locations