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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Resistant Potato Starch
Other interventionParticipants 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.
Treatment groups
11 Participants
are divided into 1 treatment groupGroup A: Resistant potato starchExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in stool short-chain fatty acid (SCFA) levels from baseline to week 4
The study team will compare the total concentrations of the 3 most abundant SCFAs in humans (acetate, propionate, and butyrate) at baseline and week 4. Stool will undergo SCFA quantification by the University of Michigan Metabolomics core.
Time frame
Baseline, Week 4Secondary outcomes
1
Change in animal naming test (ANT) from baseline to week 4
In this test patients name as many animals as they can in 60 seconds. The ANT score is the number of unique animals named.
Time frame
Baseline, Week 42
Number and type of adverse events from baseline to week 8
The severity or grade of an adverse event may be measured using the following definitions: Mild: Noticeable to the subject, but does not interfere with subject's expected daily activities, usually does not require additional therapy or intervention, dose reduction, or discontinuation of the study. Moderate: Interferes with the subject's expected daily activities, may require some additional therapy or intervention but does not require discontinuation of the study. Severe: Extremely limits to the subject's daily activities and may require discontinuation of study therapy, and/or additional treatment or intervention to resolve and may be life-threatening or fatal.
Time frame
baseline to week 83
Change in T-score for the Patient Reported Outcomes Measurement Information System (PROMIS) gastrointestinal diarrhea 6a baseline to week 4
Gastrointestinal questionnaire has six questions with a total score ranging from 1-30 with the lower score indicating a healthier status.
Time frame
Baseline, Week 44
Change in T-score for the PROMIS Gastrointestinal Gas and Bloating 13a scale baseline to week 4
The Gas and Bloating scale has13 questions (scale 2-60; with higher scores corresponding to more severe gas/bloating).
Time frame
Baseline, Week 4Sponsors and contacts
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Source ClinicalTrials.gov