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临床试验/NCT00628823
NCT00628823已完成不适用

Treatment of Mild Enteropathy Celiac Disease

Tampere University Hospital2 个研究点 分布在 1 个国家目标入组 73 人开始时间: 2003年3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
73
试验地点
2
主要终点
Small-Bowel mucosal morphology

研究概览

简要总结

The main purpose of this study is to evaluate the natural history of gluten sensitivity in endomysial antibody positive adults with celiac disease suspicion, who were found to have a only mild enteropathy (Marsh I-II) in the small-bowel mucosa. The investigators hypothesize that these subject are indeed gluten-sensitive, as measured by clinical, serological and histological indicators. If this would be the case, the current diagnostic criteria for celiac disease might need re-evaluation.

详细描述

The current diagnostic criteria of celiac disease require small-bowel mucosal villous atrophy with crypt hyperplasia (Marsh III). However, the mucosal damage develops gradually and the patients may have clinical symptoms and endomysial antibodies before the development of villous atrophy.

The main purpose of this study is to evaluate the natural history of gluten sensitivity in endomysial antibody positive adults with celiac disease suspicion, who were found to have a only mild enteropathy (Marsh I-II) in the small-bowel mucosa. We hypothesize that these subject are indeed gluten-sensitive, as measured by clinical, serological and histological indicators. If this would be the case, the current diagnostic criteria for celiac disease might need re-evaluation.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
16 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Celiac disease suspicion
  • Positive endomysial antibodies
  • At least Marsh I -type small-bowel mucosal lesion

排除标准

  • Earlier celiac disease diagnosis
  • Consuming oral corticosteroids or immune suppressants

结局指标

主要结局

Small-Bowel mucosal morphology

时间窗: one year

次要结局

  • Endomysial antibodies, tissue transglutaminase antibodies, Small-Bowel mucosal inflammation, clinical symptoms, laboratory parameters, bone mineral density.(One year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kalle Kurppa

MD., PhD

Tampere University Hospital

研究点 (2)

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