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NCT Number: NCT06425380

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

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.

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Key information

Conditions

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

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic, Rochester, Minnesota, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

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

    Time frame: Baseline, 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.

Secondary outcomes

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

    Time frame: Baseline, Week 4

    In this test patients name as many animals as they can in 60 seconds. The ANT score is the number of unique animals named.

  2. Number and type of adverse events from baseline to week 8

    Time frame: baseline to week 8

    The severity or grade of an adverse event may be measured using the following definitions:

    Mild: Noticeable to the subject, but does not interfere with subject's expected daily activities, usually does not require additional therapy or intervention, dose reduction, or discontinuation of the study.

    Moderate: Interferes with the subject's expected daily activities, may require some additional therapy or intervention but does not require discontinuation of the study.

    Severe: Extremely limits to the subject's daily activities and may require discontinuation of study therapy, and/or additional treatment or intervention to resolve and may be life-threatening or fatal.

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

    Time frame: Baseline, Week 4

    Gastrointestinal questionnaire has six questions with a total score ranging from 1-30 with the lower score indicating a healthier status.

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

    Time frame: Baseline, Week 4

    The Gas and Bloating scale has13 questions (scale 2-60; with higher scores corresponding to more severe gas/bloating).

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

    Time frame: start of screening, end of enrollment (approximately 20 months)

  6. Feasibility of completing study activities

    Time frame: baseline, week 8

    Proportion of study activities completed

  7. Feasibility based on the number of specimens collected

    Time frame: baseline, week 4

    Proportion of study samples collected (number collected from all patients / number requested from patients).

  8. Retention to end of study

    Time frame: start of screening, end of enrollment (approximately 20 months)

    Proportion of drop outs

  9. Intervention adherence

    Time frame: baseline, week 4

    Proportion of doses consumed

Study contacts

Contact information is provided by the study sponsor or research team.

Jenny Obst

CONTACT

[email protected]

507-255-1337

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
May 22, 2024
Registry last updated
Jan 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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