Clinical trial NCT06425380: Pilot Open-Label Trial of Resistant Potato Starch in Patients with Cirrhosis and Overt Hepatic Encephalopathy
Official title: Pilot Open-Label Trial of Resistant Potato Starch in Patients with Cirrhosis and Overt Hepatic Encephalopathy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Hepatic Encephalopathy
Cirrhosis
Keywords: Resistant Potato Starch
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2024-05-22
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in stool short-chain fatty acid (SCFA) levels from baseline to week 4
timeFrame: Baseline, Week 4
Secondary outcomes:
measure: Change in animal naming test (ANT) from baseline to week 4
timeFrame: Baseline, Week 4
measure: Number and type of adverse events from baseline to week 8
timeFrame: baseline to week 8
measure: Change in T-score for the Patient Reported Outcomes Measurement Information System (PROMIS) gastrointestinal diarrhea 6a baseline to week 4
timeFrame: Baseline, Week 4
measure: Change in T-score for the PROMIS Gastrointestinal Gas and Bloating 13a scale baseline to week 4
timeFrame: Baseline, Week 4
measure: Number of patients enrolled in the study as a proportion of the number of patients contacted by the study team
timeFrame: start of screening, end of enrollment (approximately 20 months)
measure: Feasibility of completing study activities
timeFrame: baseline, week 8
measure: Feasibility based on the number of specimens collected
timeFrame: baseline, week 4
measure: Retention to end of study
timeFrame: start of screening, end of enrollment (approximately 20 months)
measure: Intervention adherence
timeFrame: baseline, week 4
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Patricia Bloom, MD
role: PRINCIPAL_INVESTIGATOR
References: