NL-OMON42112已完成不适用
Identification of microbiota-specific mucosal immune responses driving primary sclerosing cholangitis (PSC) and concomitant inflammatory bowel disease (IBD).<br> - Understanding PSC-IBD
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 250
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 2 至 64(—)
入选标准
- •-Diagnosis of PSC according to generally accepted criteria (EASL diagnostic guidelines): presence of elevated serum markers of cholestasis (ALP, GGT) not otherwise explained, when MRCP or ERCP show characteristic bile duct changes with multifocal strictures and segmental dilatations, and causes of secondary sclerosing cholangitis and other cholestatic disorders are excluded;
- •-IBD (CD, UC or indeterminate colitis) confirmed by clinical evaluation in combination with endoscopic and histological investigations;
- •-Informed consent by patients or, when applicable, parents.
排除标准
- •-Diagnosis of immunodeficiency syndromes;
- •-Secondary causes of sclerosing cholangitis;
- •-Evidence of decompensated liver disease such as previous variceal bleeding, ascites, or hepatic encephalopathy;
- •-Anticipated need for liver transplantation within one year; after liver transplantation these patients will be eligible again.
- •-Findings highly suggestive of liver disease of an alternative or concomitant etiology, such as alcoholic liver disease, hepatitis B or C, haemochromatosis, Wilson*s disease, a1-antitrypsin deficiency, non-alcoholic steatohepatitis, primary biliary cirrhosis;
- •-Pregnant or lactating patients;
- •-Active illicit drug or alcohol abuse;
- •-Suspicion of ascending cholangitis or acute (septic) cholangitis or one of these events in the previous 6 months;
- •-Any infection necessitating antibiotics use >14 days in the previous 6 months.
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