Changes in Serum IL-2 Levels Following a Single Oral Dose of Gluten
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 400
- 试验地点
- 6
- 主要终点
- Change in serum interleukin-2 (IL-2) level from baseline to 4 hours after a single oral dose of gluten
研究概览
简要总结
This is a study of immune responses after eating gluten powder in people with celiac disease and healthy controls.
详细描述
This is a multi-site open-label single dose gluten challenge study. Participants will provide a blood sample for measurement of cytokines before and 4 hours after eating gluten powder.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 101 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •On a gluten-free diet for ≥ 4 weeks
- •Willing to consume gluten for research
- •For the celiac disease arm, diagnosis confirmed by serology and/or histology
排除标准
- •Wheat allergy
- •Type 1 diabetes
- •BMI z-score < -2
- •History of more than minimal symptoms following gluten exposure on a gluten-free diet
- •Comorbid condition that in the opinion of the investigator would interfere with study participation or would confound study results
研究组 & 干预措施
Healthy Controls
Individuals without a diagnosis of celiac disease
干预措施: Gluten Powder (Dietary Supplement)
Celiac Disease
Individuals with a confirmed diagnosis of celiac disease based on serology and/or histology
干预措施: Gluten Powder (Dietary Supplement)
结局指标
主要结局
Change in serum interleukin-2 (IL-2) level from baseline to 4 hours after a single oral dose of gluten
时间窗: Baseline, 4 hours
To determine the change in serum IL-2 level from baseline after a single oral dose of gluten
次要结局
未报告次要终点
研究者
Nan Du
Assistant Professor of Pediatrics
Boston Children's Hospital