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

Mayo Clinic11 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hepatic Encephalopathy Cirrhosis

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

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

Locations (2)

Mayo Clinic

Rochester, Minnesota, United States

RECRUITING

Mayo Clinic

Rochester, Minnesota, United States

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: Baseline, Week 4

Secondary Outcomes

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

Time frame: Baseline, Week 4

Number and type of adverse events from 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.

Time frame: baseline to week 8

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

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

Time frame: Baseline, Week 4

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

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

Time frame: Baseline, Week 4

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)

Feasibility of completing study activities

Proportion of study activities completed

Time frame: baseline, week 8

Feasibility based on the number of specimens collected

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

Time frame: baseline, week 4

Retention to end of study

Proportion of drop outs

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

Intervention adherence

Proportion of doses consumed

Time frame: baseline, week 4

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

Overview

Conditions

Interventions

Eligibility

Locations (2)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts