NCT02612766已完成不适用
SAFETY AND TOLERABILITY OF OAT CONTAINING GLUTEN-FREE DIET
Alfred Rusescu Institute for Mother and Child Care1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2015年11月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Change in immunological activity of the disease measured by specific antibodies
研究概览
简要总结
The purpose of this study is to determine the safety and tolerability of oats in gluten free diet.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children over 4 years and adults with celiac disease (diagnosed according to current guidelines)
- •Subject is able to fully participate in all aspects of this clinical trial
排除标准
- •Known intolerance to oats
- •Serious underlying disease other than CD which in the opinion of the investigator may interfere with the subject's ability to fully participate in the study
研究组 & 干预措施
Single Arm
Other
This is a single-arm interventional study, in which each patient gets 50 grams/day of pure, uncontaminated oats
干预措施: Pure, uncontaminated oats (Dietary Supplement)
结局指标
主要结局
Change in immunological activity of the disease measured by specific antibodies
时间窗: After 6 weeks
Change in patient symptoms assessed by validated questionnaire
时间窗: After 6 weeks
次要结局
- Palatability of oat-containing gluten-free products is evaluated through a product liking questionnaire(After 6 weeks)
研究者
研究点 (1)
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