Identification of Microbial Properties Predicting a Worsening Course of Fatty Liver Disease
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Transient Elastography Test
研究概览
简要总结
This study investigates the relation between the gastrointestinal tract bacteria and the progression of fatty liver disease .
详细描述
In the gastrointestinal (GI) tract live wide spectrum of bacteria, in this study we are trying to find if there is a relation between the GI tract bacteria and the development of non alcoholic fatty liver disease, the results of the this study may help us identify the stage of liver disease in noninvasive means and enables us to adopt methods to reduce morbodity.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with non alcoholic fatty liver disese.
- •patients who give approval to participate in the study
排除标准
- •liver failure
- •acute or chronic kidney failure
- •heart failure ( NYHA 3-4)
- •active cancer
- •fatty liver due to non alcoholic etiology.
- •patients who consume drugs from the estrogen/methotrexate family, or chloroquine.
- •history of hypothyrodism or cushing.
- •patients who used TPA in the last 6 months .
- •pathients with chronic liver disease like A1AT, hemochromatosis, wilson, toxic damage and autoimmunity .
- •special population like - children, pregnant women and patients who lack the ability to make judgment.
- •infectious liver disease - viral hepatitis or HIV.
- •inflammatory bowel disease.
- •patients who underwent surgery of the gastrointestinal trant.
结局指标
主要结局
Transient Elastography Test
时间窗: up to 2 hours
Ultrasound Elastography is a non-invasive test which uses the technology of Shear Wave Elastography (SWE) obtained from the right liver lobe for staging liver fibrosis according to Metavir Fibrosis Score . Metavir Fibrosis Score is a system used to assess the extent of inflammation and fibrosis by histopathological evaluation in a liver biopsy. Liver fibrosis assessed by Shear Wave Elastography is well correlated to biopsy using Metavir Score. The outcome of the test will be correlated to Metavir Score system according to the chart below: SWE (kiloPascal) , METAVIR score, Fibrosis Level. Below 5 , F0 , No fibrosis. 5.0-7.1 , F1 , Mild Fibrosis. 7.1-8.7 , F2 , Significant Fibrosis. 8.7-10.4 , F3 , Sever Fibrosis . 10.4-19 , F4 , Cirrhosis.
次要结局
- Gastrointestinal Microbiome test(up to 1 month)
研究者
Rawi Hazzan
Head of Liver Unit
HaEmek Medical Center, Israel