NCT07455149尚未招募不适用
An Observational Clinical Study on the Association of Intestinal Ruminococcus Gnavus and Its Derived Biogenic Amines With Metabolic Dysfunction-associated Fatty Liver Disease
Zhujiang Hospital1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2026年4月1日最近更新:
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Abundance of Ruminococcus gnavus
研究概览
简要总结
Investigating the association between intestinal Ruminococcus gnavus and its derived biogenic amines with metabolic dysfunction-associated fatty liver disease
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •1.Healthy individuals without a history of liver disease or related underlying diseases; or patients diagnosed with metabolic dysfunction-associated fatty liver disease (MAFLD) according to the latest guideline, Guidelines for the Prevention and Treatment of Metabolic (Dysfunction-Associated/Non-Alcoholic) Fatty Liver Disease (2024 Edition), meeting the following criteria: (i) imaging-based diagnosis of fatty liver and/or liver biopsy showing ≥5% macrovesicular steatosis in hepatocytes; (ii) presence of at least one component of metabolic syndrome (MetS); and (iii) exclusion of other causes of fatty liver, including excessive alcohol consumption (weekly ethanol intake ≥210 g for men and ≥140 g for women), malnutrition, hepatolenticular degeneration (Wilson's disease), and other potential etiologies.
- •2.Willingness to participate in this study and to sign the informed consent form.
- •3.Age >18 years.
排除标准
- •1. History of severe organic diseases in the liver, gastrointestinal tract, kidneys, or other systems, malignant tumors, or autoimmune diseases.
- •2. Patients who have had an acute infection or inflammatory disease within the past month.
- •3. Use of laxatives, antibiotics, probiotics, prebiotics, proton pump inhibitors, or other medications that may affect the gut microbiota within the past month.
研究组 & 干预措施
MAFLD
干预措施: observational study, no intervention (Other)
Healthy control
干预措施: observational study, no intervention (Other)
结局指标
主要结局
Abundance of Ruminococcus gnavus
时间窗: baseline
Biogenic amine levels
时间窗: baseline
次要结局
未报告次要终点
研究者
研究点 (1)
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