DRKS00003555已完成不适用
ProCeDE - Prospective Celiac Disease Diagnostic Evaluation - ProCeDE
Klinikum der Ludwig-Maximilians-UniversitätDr. von Haunersches Kinderspital0 个研究点目标入组 803 人开始时间: 2012年2月29日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 803
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
- 6 Months 至 17 Years(—)
- 性别
- All
入选标准
- •Consecutive children (age > 6 months - < 18.0 years) with a high degree suspicion for CD at a given center consuming a gluten containing diet and fullfilling one ore more of the following criteria:
- •A child with clinical symptoms (e.g. chronic or intermittent diarrhoea, weight loss, failure to thrive, abdominal pain, iron-deficiency anemia, etc.) indicative of CD plus a positive test of any titer height for CD specific antibodies (TG2 and/or EMA) or
- •A child with a increased risk for CD such as having relatives of CD patients or patients with diseases associated with CD (Hashimoto Thyroiditis, Type 1 DM, Down’s syndrome, etc.) with no or mild unspecific clinical symptoms but with a positive test for TG2 and/or a positive EMA test (>1:10).
排除标准
- •patient with symptoms that may indicate CD, but negative specific antibodies (TG2 or EMA), but normal IgA
- •patient without symptoms, and negative Anti-TG2 and negative 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
研究者
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