Risk Factors for the Development of Celiac Disease in Genetically Predisposed Children (NEOCEL)
2019年7月31日 更新者：Renata Auricchio、Federico II University
Natural History, Risk Factors and Predictive Biomarkers for Celiac Disease: a Prospective Multicenter Study.
The study aims to identify risk factors for the development of Celiac Diseases in families with a recognized genetic risk for the presence of a confirmed proband case.
Candidate mother will be recruited before a planned pregnancy or within the first 12 weeks of pregnancy.
Familial and environmental risk factors will be evaluated within the couple of parents.
Pregnancy will be followed up and appropriate biological samples collected.
Delivery will be supervised in order to collect biological samples.
Newborns will be controlled from birth up to the 6th year of age.
Data about clinical events related to health, life attitudes, nutrition will be collected together with biological samples either in the pregnant mother as well as in the infant.
研究概览
地位
邀请报名
详细说明
- CD epidemics: Celiac Disease incidence is increasing at unexpected rates in the last two decades in all gluten-consuming populations.
- Remarkable stratified genetic risk: there is a strong genetic component as the main risk to develop disease, as supported by > 85% concordance in monozygotic twins, but genetics cannot change over decades and does not explain the epidemic which has been observed. The presence of double HLA DQ2 in female subjects does increases the risk of disease above that of a mendelian recessive inheritance. Hence the estimation of environmental factors associated to the genetic risk is quite complex and does need a very strict prospective longitudinal study design, since each factor is likely to produce, if ever, a quite small odds ratio .
- Gene expression in the first year of life: we have observed, in our previous cohort studies, that the expression of at least a small set of CD associated candidate genes is substantially different between the children who eventually develop Cd and those who do not, already a 6 months of age, much before any measurable recognition of the gluten antigen, development of antibodies or any clinical sign (ref 3 Galatola).
- Epigenetic changes in small intestinal tissue: in addition of the previously reported gene expression differences, gene methylation and related expression of CD associated candidate genes have been observed in the epithelium and the lamina propria of Cd patients . In addition, microRNA appear to be differently expressed in patients versus controls.
- Early events in the first-second year of life before diagnosis: our groups and others observed that the occurrenceof acute respiratoryinfections in the first and second year of life, at least 12 months before the onset of disease, was associated to increased odds (> x2) of developing CD. It is most likely that viral infections (as the large majority of URTI in children) play a role in the development of food antigen intolerance leading to CD . A role of non-pathogenic viral infections has been also suggestedin the developmentof intolerance to gluten.
- No influence of breast-feeding or gluten introduction: breast feeding does not prevent the incidence of CD in at risk infants: its most likely effect is to delay the onset of clinical symptoms. Similarly, the time and quantity of gluten introduction is not associated to the actual incidence, but is only associated to delayed time effects.
- Possible implication of microbiome: despite the complexity of estimating differences in the composition of microbiome in the infants, it has been suggested that infants who later develop CD might show a fila composition slightly different from their matched controls.
研究类型
观察性的
注册 (预期的)
400
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Campania
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Naples、Campania、意大利、80131
- University of Naples Azienda Ospedaliera Universitaria
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 45年 (成人)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
概率样本
研究人群
Pregnant women from a family with a confirmed CD proband Live newborns from the above mothers
描述
Inclusion Criteria:
Pregnant women from a family with a confirmed CD proband
Exclusion Criteria:
Women affected by severe chronic disease and cancer Women not able to attend the schedule of visits
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学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Incidence of Celiac Disease
大体时间：6 years
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Number of new cases of infants affected by Celiac Disease in relation to genetic (HLA and non-HLA Associated Genes), Epigenetic (DNA Methylation, Gene Expression, Istone Acetylation of candidate gene) and environmental factors (Maternal factors, Nutrition, Infections)
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6 years
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Analysis of microbiome
大体时间：6 years
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Difference in the microbiome composition of the group of infants who eventually develop Celiac Disease versus those who do not develop the disease. Comparison of Fecal Microbiome of infants at 4, 12 and 24 months subgrouped by outcome. |
6 years
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2019年5月1日
初级完成 (预期的)
2022年5月1日
研究完成 (预期的)
2025年4月30日
研究注册日期
首次提交
2019年7月24日
首先提交符合 QC 标准的
2019年7月24日
首次发布 (实际的)
2019年7月26日
研究记录更新
最后更新发布 (实际的)
2019年8月2日
上次提交的符合 QC 标准的更新
2019年7月31日
最后验证
2019年7月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.