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

Обзор

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.

Вмешательства

• Другое 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.

Первичные конечные точки

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

Вторичные конечные точки (9)

• Change in animal naming test (ANT) from baseline to week 4 [Срок оценки: Baseline, Week 4]
• Number and type of adverse events from baseline to week 8 [Срок оценки: baseline to week 8]
• Change in T-score for the Patient Reported Outcomes Measurement Information System (PROMIS) gastrointestinal diarrhea 6a baseline to week 4 [Срок оценки: Baseline, Week 4]
• Change in T-score for the PROMIS Gastrointestinal Gas and Bloating 13a scale baseline to week 4 [Срок оценки: Baseline, Week 4]
• Number of patients enrolled in the study as a proportion of the number of patients contacted by the study team [Срок оценки: start of screening, end of enrollment (approximately 20 months)]
• Feasibility of completing study activities [Срок оценки: baseline, week 8]
• Feasibility based on the number of specimens collected [Срок оценки: baseline, week 4]
• Retention to end of study [Срок оценки: start of screening, end of enrollment (approximately 20 months)]
• Intervention adherence [Срок оценки: baseline, week 4]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 2 центра

• Mayo Clinic — Rochester
• Mayo Clinic — Rochester

Идентификаторы

NCT: NCT06425380 · 25-005555

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗