NCT01560169已完成不适用
Clinical Evaluation of Three Celiac Disease-Specific Patient Reported Outcome Instruments in Established and Newly Diagnosed Celiac Disease Patients
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 10
- 主要终点
- Change in symptoms using patient reported outcome instruments
研究概览
简要总结
This is an evaluation of celiac-specific patient reported outcome instruments in celiac disease patients.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of biopsy proven celiac disease
- •Adherence to a gluten-free diet (established patients only)
- •TG2 negative (established patients only)
- •TG2 positive (newly diagnosed patients only)
- •Signed informed consent
排除标准
- •History of IgE-mediated reactions to gluten
- •Significant laboratory abnormalities
- •History of untreated or GI disease
- •Positive pregnancy test
- •Any medical condition which could adversely affect study participation
结局指标
主要结局
Change in symptoms using patient reported outcome instruments
时间窗: 8 and 12 weeks
Sensitivity of the patient reported outcome instruments to detect change over time in celiac disease symptoms with and without a gluten challenge
次要结局
- Safety - incidence of adverse events(8 and 12 weeks)
研究者
研究点 (10)
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