Pilot Open-Label Trial of Resistant Potato Starch in Patients With Cirrhosis and Overt Hepatic Encephalopathy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-99
SponsorMayo Clinic
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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
Trial design
Treatments tested in this trial
- Resistant Potato Starch
Treatment groups
11 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov