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

University of Michigan

Status and phase: Enrolling; Phase 2

Conditions: Hepatic Encephalopathy; Cirrhosis

Treatments: Other: Resistant Potato Starch

Study type: Interventional

Funder types: Other

Identifiers

NCT06425380

HUM00251803

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Resistant potato starch

Experimental group

Description:

This will be taken for four weeks by enrolled participants.

Treatment:

Other: Resistant Potato Starch