跳至主要内容
临床试验/NCT07614633
NCT07614633招募中不适用

Natural History of Eosinophilic Esophagitis in Adult and Pediatric Population: a Multicentric Prospective Study in Italy

Fondazione IRCCS Policlinico San Matteo di Pavia2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2025年9月1日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
200
试验地点
2

研究概览

简要总结

Eosinophilic esophagitis (EoE) is a Th2-mediated disease induced by ingestion of ambiental and alimentary allergens. Incidence of EoE is increasing in recent years. Young male subjects are more often affected by EoE. Esophageal eosinophilic infiltrate causes different symptoms of esophageal dysfunction (i.e. dysphagia, food impaction, chest pain, heartburn). In pediatric population symptoms are nonspecific (failure to thrive, vomiting) and more common to be misdiagnosed.

Symptoms are commonly sporadic and underestimated by the patients. Therefore, specialistic evaluations are often delayed during the following months and years. Moreover, esophageal symptoms are often not investigated or associated with other diseases especially in pediatric population (i.e. gastroesophageal reflux disease). For this reason, diagnosis of EoE is often delayed. It is known from literature that diagnostic delay in EoE causes prolonged inflammation of the esophagus that may lead to esophageal fibrosis and stenosis with worsening of symptoms. Proton pump inhibitors (PPIs) and topical steroids are the first line medicines to induce EoE remission. Prolonged clinical remission is described in 60% of adult patients with PPIs. Recently orodispersible budesonide showed clinical remission after 1 year nearby in 90% of adult patients. Orodispersible budesonide is effective also in chidren with an efficacy in maintaining remission at lowest effective dosage after 60 weeks in around 78% of patients. Dysphagia Symptom Questionnaire (DSQ) is a validated tool used in order to measure clinical activity (dysphagia) in adult and pediatric patients with EoE. Italian version of the DSQ is not available in literature. Little is known in literature about the natural history of EoE patients, in particular about sustained clinical remission and appearance of complications (i.e. food impaction) during a prolonged follow-up period. Aim of our two-phase prospective study is to evaluate the clinical and endoscopic response at the current available therapies and the appearance of complications during a prolonged follow-up period in a cohort of adult and pediatric population.

详细描述

Two phases multicentre prospective observational study. In the first phase of the study, the Italian version of DSQ will be validated. In the second phase of the study, the clinical outcome of EoE patients will be investigated. Patients enrolled in the first phase will also enter in the second phase. For exploratory aim, serum and oesophageal tissue samples will be collected only in patient enrolled in S. C. General MedicineI.

研究设计

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

入排标准

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

入选标准

  • patients with an established diagnosis of Eosinophilic esophagitis;
  • aged ≥5 years;
  • who gave written informed consent.

排除标准

  • under 5 years old;
  • Patients who are illiterate;
  • Patients who are unwilling to participate

研究组 & 干预措施

Adult cohort

Adult cohort

Paediatric cohort

Paediatric cohort

结局指标

主要结局

未指定

次要结局

  • Maintenance of remission in the follow-up period in both in EoE adult and paediatric patients.(every year for 5 years total)

研究者

发起方
Fondazione IRCCS Policlinico San Matteo di Pavia
申办方类型
Other
责任方
Principal Investigator
主要研究者

Antonio Di Sabatino

Head of General Medicine I Unit

Fondazione IRCCS Policlinico San Matteo di Pavia

研究点 (2)

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