Gluten Challenge in Celiac Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 99
- 试验地点
- 2
- 主要终点
- Transcriptome of gluten-specific T cells
研究概览
简要总结
Up till 30 participants with celiac disease on a glutenfree diet are asked to consume gluten containing cookies or bread for 3 days.
Questionnaires and sampling of blood is done before, during and after.
详细描述
Before and 6 days after start of gluten challenge, blood samples will be collected and analysed by using HLA-tetramers to identify and purify CD4+ gluten-specific T cells by flow cytometry. T cells will undergo transcriptome analysis to get an insight in signalling of antigen-specific cells. Other cell populations like CD8+ T cells and γδ T cells will also be analyzed by flow cytometry.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Celiac disease confirmed by biopsy
- •Age 18 - 80 years
- •Gluten free diet last 6 months
- •Subject has received information and signed the informed consent form
排除标准
- •Pregnant or breast feeding
- •Probability of participant becoming pregnant (f.ex. by not using adequate sexual prevention by woman in fertile age)
- •Drugs influencing immune system used last 3 months
- •Current infectious disease of moderate or high severity
- •Other chronic active intestinal disease
- •Serious reaction on small amounts of gluten ingested
结局指标
主要结局
Transcriptome of gluten-specific T cells
时间窗: Day 6
Transcriptional differences of glutenspecific vs. unspecific T cells
次要结局
未报告次要终点
研究者
Knut E. A. Lundin
Professor, M.D., PhD., Consultant gastroenterologist
Oslo University Hospital