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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-12

Study Completion Date

2027-01-28

Brief Summary

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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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Detailed Description

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Conditions

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Hepatic Encephalopathy Cirrhosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Resistant potato starch

This will be taken for four weeks by enrolled participants.

Group Type EXPERIMENTAL

Resistant Potato Starch

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No