Pilot Open-Label Trial of Resistant Potato Starch in Patients With Cirrhosis and Overt Hepatic Encephalopathy

Cirrhosis Clinical Trial

Official title:

Pilot Open-Label Trial of Resistant Potato Starch in Patients With Cirrhosis and Overt Hepatic Encephalopathy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06425380
• Other study ID #: HUM00251803
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: June 2024
• Est. completion date: April 2026

Study information

• Verified date: May 2024
• Source: University of Michigan
• Contact: Max Macgregor
• Phone: 734-764-0843
• Email: mmacgreg[@]med.umich.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: April 2026
• Est. primary completion date: March 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion 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.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Brain Diseases
• Cirrhosis
• Fibrosis
• Hepatic Encephalopathy
• Liver Cirrhosis

Intervention

Other:
• Resistant Potato Starch
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.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline, Week 4
Secondary	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.	Baseline, Week 4
Secondary	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.	baseline to week 8
Secondary	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.	Baseline, Week 4
Secondary	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).	Baseline, Week 4
Secondary	Number of patients enrolled in the study as a proportion of the number of patients contacted by the study team		start of screening, end of enrollment (approximately 20 months)
Secondary	Feasibility of completing study activities	Proportion of study activities completed	baseline, week 8
Secondary	Feasibility based on the number of specimens collected	Proportion of study samples collected (number collected from all patients / number requested from patients).	baseline, week 4
Secondary	Retention to end of study	Proportion of drop outs	start of screening, end of enrollment (approximately 20 months)
Secondary	Intervention adherence	Proportion of doses consumed	baseline, week 4