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临床试验/DRKS00003555
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

发起方
Klinikum der Ludwig-Maximilians-UniversitätDr. von Haunersches Kinderspital

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