NL-OMON37411招募中不适用
Prospective Celiac Disease Diagnosis Evaluation (ProCeDE). - ProCeDE
European Society of Peadiatric Gastroenterology, Hepatology and Nutrition0 个研究点目标入组 60 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 2 至 17(—)
入选标准
- •Consecutive children (age > 6 months - < 18.0 years) with a high degree suspicion for celiac disease consuming a gluten containing diet:
- •- A child with clinical symptoms indicative of celiac disease plus a positive test of any titer specific height for celiac disease specific antibodies (TG2, EMA, DGP- cave positive DGP-titer alone does not quanlify the patient for biopsy!) or
- •- A child with an increased risk for celiac disease such as having relatives of celiac disease patients or patients with diseases associated with celiac disease (Hashimoto Thyroiditis, Type I DM, Down's symdrome) with no or mild unspecific clinical symptoms but with a positive test for celiac disease specific antibodies (positive test for TG2 and/or positive EMA (>1:10)).
排除标准
- •- Patient with symptoms that may indicate celiac disease, but negative celiac disease specific antibodies (TG2 or EMA), but normal IgA.
- •- Patient without symptoms, and negative celiac specific antibodies (TG2 and EMA)
- •- Malignancy
- •- Serious chronic infections such as HIV or tuberculosis or congenital immunodeficiency
- •- Contraindications for endoscopy/biopsies
- •- Parents did not sign consent form
- •- Parents can not read/are not able to understand to give informed consent
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