## Protocol Section
### Identification Module
**NCT ID:** NCT06425380

**Brief Title:** 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

#### Organization Study ID Info
**ID:** HUM00251803
#### Organization
**Class:** OTHER
**Full Name:** University of Michigan
### Status Module
#### Completion Date
**Date:** 2026-04

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-22

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-17

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2026-03

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-17
**Study First Submit QC Date:** 2024-05-17
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Michigan

#### Responsible Party

**Investigator Affiliation:** University of Michigan

**Investigator Full Name:** Patricia Bloom

**Investigator Title:** Assistant Professor of Internal Medicine

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Is US Export:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Hepatic Encephalopathy

- Cirrhosis

**Keywords:**

- Resistant Potato Starch

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 20

**Type:** ESTIMATED

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** This will be taken for four weeks by enrolled participants.

**Intervention Names:**

- Other: Resistant Potato Starch

**Label:** Resistant potato starch

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Resistant potato starch

**Description:** 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.

**Name:** Resistant Potato Starch

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** Change in stool short-chain fatty acid (SCFA) levels from baseline to week 4

**Time Frame:** Baseline, Week 4

#### Secondary Outcomes

**Description:** In this test patients name as many animals as they can in 60 seconds. The ANT score is the number of unique animals named.

**Measure:** Change in animal naming test (ANT) from baseline to week 4

**Time Frame:** Baseline, Week 4

**Description:** 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.

**Measure:** Number and type of adverse events from baseline to week 8

**Time Frame:** baseline to week 8

**Description:** Gastrointestinal questionnaire has six questions with a total score ranging from 1-30 with the lower score indicating a healthier status.

**Measure:** 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

**Description:** The Gas and Bloating scale has13 questions (scale 2-60; with higher scores corresponding to more severe gas/bloating).

**Measure:** Change in T-score for the PROMIS Gastrointestinal Gas and Bloating 13a scale baseline to week 4

**Time Frame:** Baseline, Week 4

**Measure:** 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)

**Description:** Proportion of study activities completed

**Measure:** Feasibility of completing study activities

**Time Frame:** baseline, week 8

**Description:** Proportion of study samples collected (number collected from all patients / number requested from patients).

**Measure:** Feasibility based on the number of specimens collected

**Time Frame:** baseline, week 4

**Description:** Proportion of drop outs

**Measure:** Retention to end of study

**Time Frame:** start of screening, end of enrollment (approximately 20 months)

**Description:** Proportion of doses consumed

**Measure:** Intervention adherence

**Time Frame:** baseline, week 4

### Eligibility Module

**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

**Maximum Age:** 75 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** mmacgreg@med.umich.edu

**Name:** Max Macgregor

**Phone:** 734-764-0843

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Ann Arbor

**Contacts:**

***Contact 1:***

- **Email:** mmacgreg@med.umich.edu

- **Name:** Max Macgregor

- **Phone:** 734-764-0843

- **Role:** CONTACT

***Contact 2:***

- **Name:** Patricia Bloom, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** United States

**Facility:** University of Michigan

**State:** Michigan

**Zip:** 48109

#### Overall Officials

**Official 1:**

**Affiliation:** University of Michigan

**Name:** Patricia Bloom, MD

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000010335

- Term: Pathologic Processes

- ID: D000008107

- Term: Liver Diseases

- ID: D000004066

- Term: Digestive System Diseases

- ID: D000002493

- Term: Central Nervous System Diseases

- ID: D000009422

- Term: Nervous System Diseases

- ID: D000017093

- Term: Liver Failure

- ID: D000048550

- Term: Hepatic Insufficiency

- ID: D000001928

- Term: Brain Diseases, Metabolic

- ID: D000008659

- Term: Metabolic Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC06

- Name: Digestive System Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M11103

- Name: Liver Cirrhosis

- Relevance: HIGH

- As Found: Cirrhosis

- ID: M9587

- Name: Hepatic Encephalopathy

- Relevance: HIGH

- As Found: Hepatic Encephalopathy

- ID: M5204

- Name: Brain Diseases

- Relevance: HIGH

- As Found: Encephalopathy

- ID: M8485

- Name: Fibrosis

- Relevance: HIGH

- As Found: Cirrhosis

- ID: M11107

- Name: Liver Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8883

- Name: Gastrointestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M7255

- Name: Digestive System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5742

- Name: Central Nervous System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M19415

- Name: Liver Failure

- Relevance: LOW

- As Found: Unknown

- ID: M25970

- Name: Hepatic Insufficiency

- Relevance: LOW

- As Found: Unknown

- ID: M5205

- Name: Brain Diseases, Metabolic

- Relevance: LOW

- As Found: Unknown

- ID: M11639

- Name: Metabolic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T2722

- Name: Hepatic Encephalopathy

- Relevance: HIGH

- As Found: Hepatic Encephalopathy

### Condition Browse Module - Meshes

- ID: D000008103

- Term: Liver Cirrhosis

- ID: D000006501

- Term: Hepatic Encephalopathy

- ID: D000001927

- Term: Brain Diseases

- ID: D000005355

- Term: Fibrosis

### Misc Info Module

- Version Holder: 2024-05-31
