Pilot Open-Label Trial of Resistant Potato Starch in Patients With Cirrhosis and Overt Hepatic Encephalopathy

NCT06425380 | Recruiting

• 1 other identifier: 25-005555
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 2

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

Keywords

Resistant Potato Starch

Outcome Measures

Primary Outcomes (1)

• Change in stool short-chain fatty acid (SCFA) levels from baseline to week 4

  The study team will compare the total concentrations of the 3 most abundant SCFAs in humans (acetate, propionate, and butyrate) at baseline and week 4. Stool will undergo SCFA quantification by the University of Michigan Metabolomics core.

  Baseline, Week 4

Secondary Outcomes (9)

• Change in animal naming test (ANT) from baseline to week 4

  Baseline, Week 4

• Number and type of adverse events from baseline to week 8

  baseline to week 8

• Change in T-score for the Patient Reported Outcomes Measurement Information System (PROMIS) gastrointestinal diarrhea 6a baseline to week 4

  Baseline, Week 4

• Change in T-score for the PROMIS Gastrointestinal Gas and Bloating 13a scale baseline to week 4

  Baseline, Week 4

• Number of patients enrolled in the study as a proportion of the number of patients contacted by the study team

  start of screening, end of enrollment (approximately 20 months)

Study Arms (1)

Resistant potato starch

EXPERIMENTAL

This will be taken for four weeks by enrolled participants.

Other: Resistant Potato Starch

Interventions

Resistant Potato Starch OTHER

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.

Resistant potato starch

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (2)

Mayo Clinic

Rochester, Minnesota, 55902, United States

RECRUITING

Mayo Clinic

Rochester, Minnesota, 55905, United States

RECRUITING

MeSH Terms

Conditions

Hepatic Encephalopathy; Fibrosis

Condition Hierarchy (Ancestors)

Liver Failure; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases; Brain Diseases, Metabolic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Patricia Bloom, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jenny Obst

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 17, 2024
• First Posted: May 22, 2024
• Study Start: July 12, 2024
• Primary Completion (Estimated): January 28, 2027
• Study Completion (Estimated): January 28, 2027
• Last Updated: January 30, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)