NCT06425380招募中不适用
Pilot Open-Label Trial of Resistant Potato Starch in Patients With Cirrhosis and Overt Hepatic Encephalopathy
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 11
- 试验地点
- 3
- 主要终点
- Change in stool short-chain fatty acid (SCFA) levels from baseline to week 4
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Resistant potato starch
Experimental
This will be taken for four weeks by enrolled participants.
干预措施: Resistant Potato Starch (Other)
结局指标
主要结局
Change in stool short-chain fatty acid (SCFA) levels from baseline to week 4
时间窗: Baseline, 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.
次要结局
- Feasibility of completing study activities(baseline, week 8)
- 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))
- Intervention adherence(baseline, week 4)
- Number and type of adverse events from baseline to week 8(baseline to week 8)
- Change in T-score for the Patient Reported Outcomes Measurement Information System (PROMIS) gastrointestinal diarrhea 6a baseline to week 4(Baseline, Week 4)
- Retention to end of study(start of screening, end of enrollment (approximately 20 months))
- Change in animal naming test (ANT) from baseline to week 4(Baseline, Week 4)
- Change in T-score for the PROMIS Gastrointestinal Gas and Bloating 13a scale baseline to week 4(Baseline, Week 4)
- Feasibility based on the number of specimens collected(baseline, week 4)
研究者
Patricia P. Bloom
Principal Investigator
Mayo Clinic
研究点 (3)
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