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

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Mayo Clinic
Study ID
NCT06425380
Status
Recruiting
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Conditions

  • Cirrhosis
  • Hepatic Encephalopathy

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • Resistant Potato Starch — OTHER
    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 Details

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.

Key Dates

Start date
Jul 12, 2024
Status verified
Jan 2026
Primary completion
Jan 28, 2027
Completion
Jan 28, 2027

Study Design

Enrollment
11 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Resistant potato starch
    This will be taken for four weeks by enrolled participants.

Primary Outcome Measure

Change in stool short-chain fatty acid (SCFA) levels from baseline to week 4 [ Time Frame: Baseline, Week 4 ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Mayo ClinicRochesterMinnesota55902
Jenny Obst
[email protected]
507-255-1337
Patricia Bloom, MD (PRINCIPAL_INVESTIGATOR)
Mayo ClinicRochesterMinnesota55905-

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Mayo Clinic· Rochester, MN

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