Could potato starch help liver patients think clearly?
NCT ID NCT06425380
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This pilot study at Mayo Clinic is testing whether a dietary supplement called resistant potato starch can change gut bacteria in people with cirrhosis who have had episodes of confusion (hepatic encephalopathy). Eleven participants will take 20 grams of potato starch twice daily for 4 weeks. Researchers will measure changes in stool short-chain fatty acids and a simple animal-naming test to see if the starch affects brain function.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Resistant potato starch (Bob's Red Mill® potato starch)
- What this could lead to
- If it works, this could point toward a simple dietary supplement to help manage hepatic encephalopathy by improving gut health.
- What could go wrong
- This is a very small pilot study with only 11 people and no placebo group. It is designed to see if the starch changes gut bacteria, not to prove it treats symptoms. Results may not lead to a treatment.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 11 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2024
- Expected to finish
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Jan 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 99 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Mayo Clinic
RECRUITINGRochester, Minnesota, 55902, United States
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Mayo Clinic
RECRUITINGRochester, Minnesota, 55905, United States
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- Could common heartburn drugs raise brain risk after liver shunt?