Recruiting

Resistant Potato Starch

Sponsor:

Mayo Clinic

Code:

NCT06425380

Conditions

Hepatic Encephalopathy

Cirrhosis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Resistant Potato Starch

Study Details

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.

Conditions

Hepatic Encephalopathy

Cirrhosis

Study ID

NCT06425380

Start date

Jul 12, 2024

Status verified date

Jan, 2026

Completion date

Jan 28, 2027

Anticipated

Primary completion date

Jan 28, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

11 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Resistant potato starch

This will be taken for four weeks by enrolled participants.

Interventions

Resistant Potato Starch

Participants will receive 4 weeks of resistant potato starch 20 grams (g) twice daily. Bob's Red Mill® potato starch will be used. Every patient will receive the same dose and there are no dose titrations.

Primary outcome measure

  • Change in stool short-chain fatty acid (SCFA) levels from baseline to week 4 [ Time Frame: Baseline, Week 4 ]

Central Contacts and Locations

Central contacts

Jenny Obst

507-255-1337obst.jenny@mayo.edu

Locations

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55902

Contacts

Jenny Obst

507-255-1337obst.jenny@mayo.edu

Principal Investigator:

Patricia Bloom, MD

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55905

More Information

Sponsor

Mayo Clinic

Last update posted

Jan 30, 2026

Last verified

Jan, 2026

Keywords

  • Resistant Potato Starch

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-01-30.