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临床试验/NCT02072590
NCT02072590已完成不适用

Improved Diagnostics of Celiac Disease in Children

Tampere University Hospital2 个研究点 分布在 2 个国家目标入组 300 人开始时间: 2011年8月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
300
试验地点
2
主要终点
Transglutaminase 2 antibodies

研究概览

简要总结

The main purpose of this study is to improve the diagnostics of celiac disease and reduce the need for invasive endoscopic studies in children. Further, the investigators aim to investigate the natural history and risk of complications in children with celiac disease or gluten sensitivity and to create a large scientific database.

详细描述

Prevalence of celiac disease is on a steep rise in Western countries, but due to difficult diagnosis the majority of patients remain unrecognized. Undiagnosed celiac disease causes incremental burden to the health care and predisposes to severe complications. On the other hand, increasing screening in at-risk groups of celiac disease frequently detects seropositive subjects with no obvious symptoms and/or still normal small-bowel mucosal morphology. At present the natural history and benefits of an early diagnosis in such individuals is poorly known. Further, the endoscopic demonstration of the small-intestinal damage required for the diagnosis is unpleasant, expensive and often misleading. New serology-based diagnostic criteria have been suggested but prospective data is lacking. Aims of the present study are to improve the diagnostic yield and accuracy of the current diagnostic methods and to develop novel non-invasive methods and biomarkers for early detection of celiac disease. In addition, the investigators will evaluate natural history of celiac disease in screening-detected asymptomatic children and in those with positive serology but normal histology, and form a large database for future clinical and translational studies. The study and patient collection are to be conducted at the pediatric clinics in Finland and in Romania. All children referred due to suspicion of celiac disease or gluten sensitivity will be asked to participate to the study. Patient samples and clinical information are collected during the routine visits and the study does not include any additional visits or endoscopies. The total duration of the study is 10 years but data will be analyzed on-line.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
0 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Suspicion of celiac disease or gluten sensitivity
  • Age below 18 years

排除标准

  • Study refusal
  • Age 18 years or more

结局指标

主要结局

Transglutaminase 2 antibodies

时间窗: Baseline and after 3 months, 6 months and 1 year on a gluten-free diet

Change of the transglutaminase 2 antibody levels on a gluten-free diet

次要结局

  • Visual Analog Scale(Baseline and after 3 months, 6 months and 1 year on a gluten-free diet)
  • Height(Baseline and after 3 months, 6 months and 1 year on a gluten-free diet)
  • Weight(Baseline and after 3 months, 6 months and 1 year on a gluten-free diet)
  • Serum endomysial antibodies(Baseline and after 3 months, 6 months and 1 year on a gluten-free diet)
  • Dietary compliance(After 3 months, 6 months and 1 year on a gluten-free diet)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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