跳至主要内容
临床试验/NCT07070596
NCT07070596招募中不适用

NATURCEL Registry: Study of the NATURal History, Epidemiological, Clinical, Diagnostic and Therapeutic Aspects of CELiac Disease and Non-celiac Enteropathies

Hospital Mutua de Terrassa1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2025年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
1,000
试验地点
1
主要终点
Proportion of patients with confirmed celiac disease diagnosis based on serologic and histologic criteria among those with suspected celiac disease

研究概览

简要总结

Celiac disease is a chronic immune-mediated enteropathy triggered by gluten intake, which affects the small intestine in genetically susceptible subjects (HLA-DQ2 and/or HLA-DQ8). Affecting both children and adults, it is among the most common genetically determined disorders in Western countries. The disease is characterized by clinical manifestations (mainly digestive symptoms and signs of intestinal malabsorption), the presence of specific antibodies (tissue transglutaminase and endomysium) and enteropathy. Currently, the only treatment for celiac disease is a strict gluten-free diet for life.

The main objective of the NATURCEL registry (Study of the NATURal history, epidemiological, clinical, diagnostic and therapeutic aspects of celiac disease and non-celiac enteropathies) is to collect a wide range of data (epidemiological, clinical, genetic, immunological, etc.) for scientific and translational purposes.

The registry will include individuals diagnosed with celiac disease or other gluten-related disorders, as well as patients with non-celiac enteropathies evaluated for suspected celiac disease. In the future, the project also aims to establish a biobank-an organized repository of biological samples-to further support scientific and medical research in this field.

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • Individuals under diagnostic evaluation for celiac disease

排除标准

  • Failure to sign informed consent

结局指标

主要结局

Proportion of patients with confirmed celiac disease diagnosis based on serologic and histologic criteria among those with suspected celiac disease

时间窗: End of diagnostic evaluation (up to 10 weeks after inclusion)

次要结局

未报告次要终点

研究者

发起方
Hospital Mutua de Terrassa
申办方类型
Other
责任方
Sponsor

研究点 (1)

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