Hepatic EncephalopathyNCT06425380
Pilot Open-Label Trial of Resistant Potato Starch in Patients With Cirrhosis and Overt Hepatic Encephalopathy
A study testing Resistant Potato Starch in people with Hepatic Encephalopathy and Cirrhosis, run by Mayo Clinic at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Hepatic Encephalopathy, Cirrhosis
- What is being tested?
- Resistant Potato Starch
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 2 sitesUnited States
- Study dates
- 12 Jul 2024to 28 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 15Show fewer
- 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 locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55902
Jenny Obst, 507-255-1337, obst.jenny@mayo.edu
Patricia Bloom, MD
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55905
About this study
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.
- Conditions
- Hepatic Encephalopathy, Cirrhosis
- Being tested
- Resistant Potato Starch
- Keywords
- Resistant Potato Starch
- Medical subject headings
- Hepatic Encephalopathy, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistant Potato StarchOther
Participants 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.
| Study group | Role | What they receive |
|---|---|---|
| Resistant potato starch | Experimental | This will be taken for four weeks by enrolled participants. Receives: Other: Resistant Potato Starch |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Week 4
Secondary outcomes (9)
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.
Measured: Baseline, Week 4
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.
Measured: baseline to week 8
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.
Measured: Baseline, Week 4
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).
Measured: Baseline, Week 4
Number of patients enrolled in the study as a proportion of the number of patients contacted by the study team
Measured: start of screening, end of enrollment (approximately 20 months)
Feasibility of completing study activities
Proportion of study activities completed
Measured: baseline, week 8
Feasibility based on the number of specimens collected
Proportion of study samples collected (number collected from all patients / number requested from patients).
Measured: baseline, week 4
Retention to end of study
Proportion of drop outs
Measured: start of screening, end of enrollment (approximately 20 months)
Intervention adherence
Proportion of doses consumed
Measured: baseline, week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2024
- Study start12 Jul 2024
- Primary completion28 Jan 2027 (estimated)
- Study completion28 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic EncephalopathyStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patricia P. Bloom, Mayo Clinic
- Investigators
- Patricia Bloom, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06425380
- Sponsor's protocol ID
- 25-005555
- Status last verified
- Jan 2026
- First submitted
- 17 May 2024
- Last updated
- 30 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Open-Label Trial of Resistant Potato Starch in Patients With Cirrhosis and Overt Hepatic Encephalopathy
- ClinicalTrials.gov ID
- NCT06425380
- Acronym / sponsor ID
- 25-005555
- Conditions
- Hepatic Encephalopathy, Cirrhosis
- Keywords
- Resistant Potato Starch
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 11 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 12 Jul 2024 (actual)
- Primary completion
- 28 Jan 2027 (estimated)
- Study completion
- 28 Jan 2027 (estimated)
- First posted
- 22 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Resistant potato starch | Experimental | Other: Resistant Potato StarchThis will be taken for four weeks by enrolled participants. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
- 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.
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resistant Potato StarchParticipants 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. | Other | Resistant potato starch |
Primary outcome
Change in stool short-chain fatty acid (SCFA) levels from baseline to week 4
Time frame: Baseline, 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.
9 secondary outcomes
Change in animal naming test (ANT) from baseline to week 4
Time frame: Baseline, Week 4
Number and type of adverse events from baseline to week 8
Time frame: baseline to week 8
Change in T-score for the Patient Reported Outcomes Measurement Information System (PROMIS) gastrointestinal diarrhea 6a baseline to week 4
Time frame: Baseline, Week 4
Change in T-score for the PROMIS Gastrointestinal Gas and Bloating 13a scale baseline to week 4
Time frame: Baseline, Week 4
Number of patients enrolled in the study as a proportion of the number of patients contacted by the study team
Time frame: start of screening, end of enrollment (approximately 20 months)
Feasibility of completing study activities
Time frame: baseline, week 8
Feasibility based on the number of specimens collected
Time frame: baseline, week 4
Retention to end of study
Time frame: start of screening, end of enrollment (approximately 20 months)
Intervention adherence
Time frame: baseline, week 4
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Patricia Bloom, MD principal investigator
Mayo Clinic
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resistant Potato Starch in people with Hepatic Encephalopathy and Cirrhosis, run by Mayo Clinic at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jenny Obst (507-255-1337, obst.jenny@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in stool short-chain fatty acid (SCFA) levels from baseline to week 4 (time frame: Baseline, Week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2026.