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临床试验/NCT05094232
NCT05094232已完成不适用

Epidemiologic Evolution of Coeliac Disease in Spain and Risk Factors Influencing Disease Prevalence

Hospital Mutua de Terrassa2 个研究点 分布在 1 个国家目标入组 4,826 人开始时间: 2020年11月1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
4,826
试验地点
2
主要终点
tissue transglutaminase IgA antibodies (tTGA) detection in blood serum (serological CD marker)

研究概览

简要总结

Previous studies have showed that Coeliac Disease (CD) prevalence is significantly higher in children compared with adults. The largest epidemiologic study carried out in Spain to date (n=4230) reported a higher CD prevalence in children (1:71) than in adults (1:357) during 2004-2007. To study whether this difference was due to environmental factors influencing infancy or the development of gluten tolerance with age, a natural history study in pediatric age was initiated in 2013. Unexpectedly, the prevalence in children of 1-2 years of age was lower (1:135) than the previously reported in 2004-2007 for that age group (1:25). During follow-up, 1/3 of the asymptomatic cases showed reversion of the intestinal lesion and/or negativization of CD serological markers while continuing on a gluten-containing diet. Therefore, the development of gluten tolerance seems to have a major effect in age-related differences in CD prevalence. However, gluten tolerance phenomenon does not explain the differences found between the 2013-2019 and the 2004-2007 cohorts, suggesting that environmental factors may contribute as well. Apart from genetic factors, several environmental factors are believed to influence disease appearance, such as the time that gluten is introduced to the diet, viral infections, type of birth, antibiotic treatments, etc. Therefore, development of tolerance and environmental factors seem to equally play an important role in age-related differences in CD prevalence. However, more data is needed in order to know how environmental factors influence disease prevalence in Spain. Also, the previous studies carried in Spain were performed in specific geographical areas: Asturias, Basque Country and Catalonia using slightly different methodology and focused on different age groups, thus making results comparison and global extrapolation challenging.

In this study, the investigators aim to determine global CD prevalence in Spain during 2020-2021 and: 1) compare it with the results obtained in previous studies; and 2) identify whether there are any differences associated with age, environmental factors and/or geographical area. For this purpose: a) participants are recruited based on the reference population regarding age and gender; b) recruitment is done in 5 different geographical areas in Spain: Andalusia, Asturias, Basque Country, Catalonia and Madrid; c) relevant clinical, social and environmental data is collected and d) serologic screening (anti-tissue transglutaminase (tTG) - Immunoglobulin A (IgA) antibodies detection in blood serum) with histological confirmation (small-intestinal biopsy) is used to detect CD cases and determine disease prevalence.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

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

入选标准

  • Age 1 to ≥80 years old

排除标准

  • Heart failure or unstable ischemic cardiopathy
  • Chronic obstructive pulmonary disease or respiratory insufficiency
  • Coagulopathy
  • Diabetes mellitus type II with vascular complications
  • Hepatic cirrhosis
  • Kidney failure (Creatinine >1.5 mg/dL o glomerular filtration <30 ml /min)
  • Active neoplasm
  • Pregnancy
  • Gluten-free diet without CD diagnosis

结局指标

主要结局

tissue transglutaminase IgA antibodies (tTGA) detection in blood serum (serological CD marker)

时间窗: at the time of recruitment

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 (2)

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