NCT06425380 Pilot Open-Label Trial of Resistant Potato Starch in Patients With Cirrhosis and Overt Hepatic Encephalopathy
| NCT ID | NCT06425380 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Mayo Clinic |
| Condition | Hepatic Encephalopathy |
| Study Type | INTERVENTIONAL |
| Enrollment | 11 participants |
| Start Date | 2024-07-12 |
| Primary Completion | 2027-01-28 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 11 participants in total. It began in 2024-07-12 with a primary completion date of 2027-01-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Patricia Bloom, MD
PRINCIPAL INVESTIGATOR
Mayo Clinic
Frequently Asked Questions
Who can join the NCT06425380 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 99 Years, studying Hepatic Encephalopathy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06425380 currently recruiting?
Yes, NCT06425380 is actively recruiting participants. Contact the research team at obst.jenny@mayo.edu for enrollment information.
Where is the NCT06425380 trial being conducted?
This trial is being conducted at Rochester, United States, Rochester, United States.
Who is sponsoring the NCT06425380 clinical trial?
NCT06425380 is sponsored by Mayo Clinic. The principal investigator is Patricia Bloom, MD at Mayo Clinic. The trial plans to enroll 11 participants.