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New treatment option for Hepatic Encephalopathy
Official title Pilot Open-Label Trial of Resistant Potato Starch in Patients With Cirrhosis and Overt Hepatic Encephalopathy
ClinicalTrials.gov ID: NCT06425380
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 99
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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.
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Rochester, Minnesota, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 99 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Rochester, Minnesota, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.