Outcomes of Children With Eosinophilic Esophagitis: a Prospective Monocentric Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Determine the rate of complete remission
研究概览
简要总结
The investigator would like to create a prospective cohort of patients in order to describe eosinophilic esophagitis with the specificities corresponding to our geographical territory, and to study their evolution at 3 months, 6 months, 12 months, 18 months and 24 months.
This study would also enable us to investigate the quality of life of these chronically ill patients
详细描述
The investigator would like to create a prospective cohort of 16 patients included over 2 years in order to determine the rate of complete remission (clinical, endoscopic and histological) at 3 months, 6 months, 12 months, 18 months and 24 months of treatment initiation. It is also planned to describe this cohort of pediatric EO patients at inclusion and throughout follow-up, and to study their quality of life.
Follow-up visits is organized every 3 months with a gastropediatrician, who assesses the patient's symptoms (PEESS score) and quality of life (PedsQL eosinophilic esophagitis module and PedsQL 4.0 Generic Core Scales).
If treatment needs to be introduced or changed, a digestive endoscopy with biopsies will be carried out at 3 months to determine whether the patient is in remission or not.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of OE according to the diagnostic criteria of the PNDS published in July 2022
- •Due to start treatment.
- •informed consent from one of the 2 parents or the representative of parental authority.
- •Membership of a social security scheme.
排除标准
- 未提供
研究组 & 干预措施
Management of eosinophilic esophagitis
Follow-up visits are always organized in the same way. A consultation with a gastropediatrician will take place, with assessment of symptoms (PEESS score) and quality of life (PedsQL module for eosinophilic esophagitis and PedsQL 4.0 Generic Core Scales). Then, if treatment needs to be introduced or changed, a digestive endoscopy with biopsies will be carried out at 3 months to determine whether the patient is in remission or not. Depending on the results, the patient may be advised to adapt or maintain the current treatment.
干预措施: Digestive endoscopy (Other)
结局指标
主要结局
Determine the rate of complete remission
时间窗: at 3 months, 6 months, 12 months, 18 months and 24 months from treatment initiation.
Complete remission will be defined according to the following criteria: 1. Abolition of clinical symptoms as assessed by the Pediatric Eosinophilic Esophagitis Symptom Score 2. Endoscopic score: EoE Endoscopic Reference Score (EREFS) ≤ 2 in the lower, middle and upper thirds of the esophagus. 3. Eosinophilic infiltrate \< 5/HPF in standard HES (Haemato-Eosin-Safran) stain on biopsies from lower, middle and upper thirds of esophagus 4. No therapeutic change at follow-up visit to assess remission
次要结局
- evolution of quality of life(at diagnosis, 3 months, 6 months, 12 months, 18 months and 24 months of treatment)
- Description at inclusion of a cohort of pediatric patients with OE(throught a 24 months follow-up)