Resistant Potato Starch for Liver Cirrhosis

Phase 2

Recruiting

Led By Patricia Bloom, MD

Research Sponsored by University of Michigan

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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 or can be precipitated Hepatic Encephalopathy (HE) episode

Must not have

Current refractory ascites (requiring large volume paracentesis to manage ascites)

History of inflammatory bowel disease

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

No Placebo-Only Group

Summary

This trial is looking at how a dietary supplement made from potato starch called resistant potato starch affects the gut bacteria of people with liver conditions. Participants will take the supplement, and researchers will collect health information and

Who is the study for?

This trial is for individuals with liver cirrhosis and overt hepatic encephalopathy, which is a decline in brain function due to severe liver disease. Participants should be willing to consume resistant potato starch and provide health information as well as stool samples for research purposes.

What is being tested?

The study is testing the effects of resistant potato starch, a dietary supplement derived from potatoes, on gut bacteria in patients with cirrhosis and hepatic encephalopathy. The goal is to understand how this food product influences the body's response.

What are the potential side effects?

Potential side effects are not specified but may include digestive discomfort or changes in bowel habits due to the introduction of new dietary fiber from the resistant potato starch.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with cirrhosis.

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I have had a serious episode of brain dysfunction due to liver disease in the last year.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I need frequent procedures to remove fluid from my abdomen.

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I have a history of inflammatory bowel disease.

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I have been diagnosed with dementia or another cognitive disorder.

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I have a history of primary sclerosing cholangitis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ start of screening, end of enrollment (approximately 20 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~start of screening, end of enrollment (approximately 20 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and start of screening, end of enrollment (approximately 20 months) for reporting.