National, Multicenter, Retrospective, Prospective Study to Evaluate Pediatric Gastrointestinal Eosinophilic Disorders
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Incidence estimates
研究概览
简要总结
Eosinophilic gastrointestinal disorders (EGIDs) are a heterogeneous group of emerging chronic inflammatory diseases that may affect different gastrointestinal (GI) tracts. Based on the anatomical site involved, EGIDs are distinguished into eosinophilic esophagitis (EoE) and non-esophageal forms, which are subdivided into eosinophilic gastritis (EoG), gastroenteritis (EoGE), and colitis (EoC). EoE is considered the prototype of EGIDs. Since the first description of a case series of patients with EoE, fundamental scientific advances have been achieved, culminating in the redaction of international diagnostic and therapeutic guidelines. In contrast to EoE, non-esophageal forms of EGIDs are still a clinical enigma with evidence limited to a few retrospective studies. In the last decade, an increase in the prevalence of EGIDs has been observed in the pediatric age. Unfortunately, the epidemiology of EGIDs in Italy is still inconsistent and clear estimates are not available.
Firstly, this study will allow us to assess and clarify several clinical and epidemiological aspects of pediatric EGIDs, in particular:
- prevalence and incidence of pediatric EGIDs in Italy,
- the clinical features and potential phenotypes of pediatric EGIDs with potential impact on therapy and management,
- diagnostic work-up and adherence to the EoE international guidelines to improve the management, quality of care, and quality of life of affected patients.
This study has no ethical problems since EoE patients are treated according to international guidelines and those with non-esophageal EGIDs according to the latest scientific evidence.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 0 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All EGIDs patients aged 0-18 years and followed at the centers involved in the study will be considered eligible. Informed consent must be obtained from each enrolled patient and signed by a parent/legal guardian and patient (when older than six years).
排除标准
- •This study will not include patients with:
- •a diagnosis of EGIDs made more than five years before the study participation;
- •a diagnosis of EoE not in line with current international guidelines;
- •a secondary cause of intestinal eosinophilic inflammation (inflammatory bowel diseases, autoimmune diseases, vasculitis, graft versus host disease, malignancies).
结局指标
主要结局
Incidence estimates
时间窗: 5 years
b) If available the cumulative incidence (new EGIDs cases) may be derived, as a subgroup analysis of the primary endpoint
Prospective epidemiological estimates
时间窗: 5 years
a) To estimate the cumulative incidence of EGIDs (new diagnosis of EGIDs) over the study period.
Prevalence estimates
时间窗: 5 years
a) To estimate the EGIDs prevalence in patients with gastrointestinal symptoms undergoing upper and lower GI endoscopy, to verify whether the global increase of EGIDs also affects the Italian reality
次要结局
- Improvement of diagnostic and therapeutic management(5 years)
- Definition of clinical features and potential phenotypes(5 years)
- Other epidemiological estimates(5 years)
研究者
Amelia Licari
Principal Investigator
Fondazione IRCCS Policlinico San Matteo di Pavia