Evaluation of Alterations in Serum Inflammatory Markers and Fecal Microbiota Following Administration of the Probiotic Formulation VSL#3 in Patients With Nonalcoholic Fatty Liver Disease
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Change in Il-17 levels with probiotic administration
研究概览
简要总结
Individuals with clinically identified non-alcoholic fatty liver disease will undergo baseline evaluation of IL-17 and other inflammatory markers as well as microbiome determination. The probiotic formulation VSL#3 450 Billion CFU twice daily will be administered for 8 weeks and the determination of Il-17 and microbiome will be repeated. Each subject will serve as his or her own control.
详细描述
This study is designed as a prospective trial of the effects of probiotic on inflammatory and stool profiles in patients with NAFLD. These patients are actively followed by the Division of Hepatology. They will have confirmed normal liver function tests and absence of hepatitis C virus in order to be eligible for this study. Eligible subjects will be identified within the outpatient setting of the Division of Hepatology of the Northwell Health System.
Division of Hepatology 400 Community Drive Manhasset, NY 11030 516-562-4281
Candidate subjects will be identified by investigators as a part of their typical work flow. Subjects will be evaluated according to inclusion and exclusion criteria presented. Eligible patients will be provided with a packet containing study information and informed consent documents. Should a patient remain interested in study participation, informed consent will be obtained. Financial compensation will not be provided to subjects.
Forty patients with NAFLD will be enrolled.
Following enrollment and informed consent, subjects will undergo the following assessments:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years of age or older
- •Capable of giving informed consent
- •Diagnosed with NAFLD as defined by the American Association for the Study of Liver Diseases (AASLD) who are treated or seen solely at the outpatient clinic at the Department of Hepatology at 400 Community Drive in Manhasset NY
排除标准
- •Cirrhosis
- •Absence of secondary causes of hepatic fat accumulation including:
- •Excessive alcohol consumption
- •Hepatitis C
- •Wilson's Disease
- •Lipodystrophy
- •Starvation
- •Parenteral Nutrition
- •Abetalipoproteinemia
- •Specific Medications: Amiodarone, Methotrexate, Tamoxifen, Corticosteroids, Valproate, Anti-retroviral agents)
- •Reye's Syndrome
- •HELLP Syndrome
- •Inborn errors of metabolism (LCAT deficiency, cholesterol ester storage disease, Wolman disease)
结局指标
主要结局
Change in Il-17 levels with probiotic administration
时间窗: 8 weeks
Percent decrease in Il levels will be recorded.
次要结局
未报告次要终点
研究者
Bruce Hirsch
Assistant Professor of Medicine
Northwell Health