A Blood Based Diagnostic Test for Coeliac Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 144
- 试验地点
- 1
- 主要终点
- Ability of the tetramer test in differentiating persons with coeliac disease from controls by the use of tetramer staining for gluten specific T-cells and flowcytometry
研究概览
简要总结
Persons with coeliac disease treated with a gluten free diet will be asked to give blood for a new diagnostic blood test. In this test investigators will use multimerized HLA bound to different gliadin-peptides (tetramer) and with the help of a flow-cytometer identify (along with other relevant T-cell-markers) gluten specific T-cells. Investigators believe that these cells will be present in persons with coeliac disease regardless of gluten-intake. Investigators will compare their findings with two control groups; Persons on a gluten free diet where celiac disease is excluded (gluten sensitive group) and persons on a gluten containing diet (healthy control group). In the initial and main study investigators will look at HLA DQ2.5 individuals, which comprise >90% of all persons with coeliac disease.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
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
- •HLA DQ2.5 positives in primary blinded study (other HLA-types ie DQ8 and DQ2.2 in later unblinded study)
- •In gluten free group: Diagnosis must be confirmed by duodenal biopsy done after sufficient time on gluten containing diet and participant must have followed a glutenfree diet since.
排除标准
- •Drugs that influence the immune system used last three months
- •Infected with Hepatitis B, C or HIV
结局指标
主要结局
Ability of the tetramer test in differentiating persons with coeliac disease from controls by the use of tetramer staining for gluten specific T-cells and flowcytometry
时间窗: Upto 20 months
次要结局
未报告次要终点
研究者
Knut E. A. Lundin
Associate professor, phD, MD
Oslo University Hospital