Soluble Syndecan 1 as Biomarker for Acute and Chronic Bowel Inflammation
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Soluble serum Syndecan-1 in ng/ml
研究概览
简要总结
The aim of the study is to evaluate the soluble biomarker syndecan-1 (sSdc1) taken from venous blood of patients with infectious intestinal diseases such as Clostridium difficile-associated colitis, bacterial colitis, Norovirus enteritis and Crohn´s disease or ulcerative colitis. The level of sSdc1 will be compared with disease activity in patients with active inflammation and with disease in remission. Secondary objectives were the assessment of correlation of the above-mentioned factors with the CRP value. Subjects will be volunteers. Blood will be taken as part of the routine clinical work-up after the written agreement blood and sSdc1-level will be assessed using a human-specific sSdc1 ELISA assay. In addition, the subjects are asked to answer a short questionnaire. The study is designed as a prospective, comparative cohort study.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- •Subject with at least 18 years of age
- •able to give informed consent
- •healthy volunteer or inflammatory bowel condition (inflammatory bowel disease, infectious colitis)
排除标准
- •not able to give informed consent
结局指标
主要结局
Soluble serum Syndecan-1 in ng/ml
时间窗: 6 months
次要结局
- Disease activity in Inflammatory bowel disease(6 Months)
- Calprotectin in stool(6 Months)
- CRP in serum(6 Months)
- Underlying disease(6 months)
- Patient age(6 Months)
- Leucocyte blood count(6 Months)
研究者
Tobias Meister
Priv.-Doz. Dr. med. Tobias Meister
Helios Albert-Schweitzer-Klinik Northeim