Prospective Multicenter Nationwide Registry of Children With Eosinophilic Esophagitis

• Conditions: Eosinophilic Esophagitis
• Interventions: Other: no intervention

• Registration Number: NCT03858426
• Lead Sponsor: Sociedad Espanola de Gastroenterologia, Hepatologia y Nutricion Pediatrica

Brief Summary

1. Registry of demographic, clinical, endoscopic and histological data at baseline.

2. Registry of patients treated with PPI:

* Clinical, endoscopic and histological response at 8-12 weeks of induction treatment

* Clinical, endoscopic and histological response at 6 and 12 months weeks of maintenance treatment

3. Registry of patients treated with two foods elimination diet:

* Clinical, endoscopic and histological response at 8-12 weeks of induction treatment

* Identification of food trigger: milk, gluten or milk and gluten

* Clinical, endoscopic and histological response at one year elimination of food trigger

* Registry of adverse events

4. Registry of patients treated with swallowed steroids (budesonide or fluticasone):

* Clinical, endoscopic and histological response at 8-12 weeks of induction treatment

* Clinical, endoscopic and histological response at 6 months of maintenance steroid treatment

* Registry of adverse events

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-10-11
• Study Start: 2019-01-01
• Status Verified: 2019-02
• Study First Submitted QC: 2019-02-26
• Last Update Submitted: 2019-02-26
• Study First Posted: 2019-02-28
• Last Update Posted: 2019-02-28
• Primary Completion: 2020-11-01
• Study Completion: 2022-07-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• Children from 1 month to 18 years with a new diagnosis of eosinophilic esophagitis (EoE) according to the recent European guidelines (symptoms of esophageal dysfunction + eosinophilic infiltrate of the esophagus > 15 eos / CGA)
• And that they need to start treatment with any of the following options: PPI, diet excluding cow's milk and gluten, or swallowed corticosteroids .

Exclusion Criteria

• Presence of pathological eosinophilia at the gastric or duodenal level (eosinophilic gastroenteritis)
• Simultaneous treatment with more than one treatment modality (PPI, empirical elimination diet, swallowed corticosteroids).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Children with eosinophilic esophagitis	no intervention	Inclusion criteria: * Children from 1 month to 18 years with a new diagnosis of eosinophilic esophagitis according to recent European guidelines (symptoms of esophageal dysfunction + eosinophilic infiltrate of the esophagus \> 15 eos / CGA) * And they need to start treatment with one of the following options: PPI, diet excluding cow's milk and gluten, or swallowed corticosteroids Exclusion criteria: * Presence of pathological eosinophilia at the gastric or duodenal level (eosinophilic gastroenteritis) * Simultaneous treatment with more than one treatment modality (PPI, empirical elimination diet, swallowed corticosteroids).

Primary Outcome Measures

Name	Time	Method
Complete histological remission	12 weeks	Complete histological remission response defined as ≤5 eosinophils/hpf in all biopsies performed

Secondary Outcome Measures

Name	Time	Method
Partial histological remission	12 weeks	Partial histological remission response defined as 5-15 eosinophils /hpf in all biopsies
Clinical remission	12 weeks	Clinical remission (specific questionnaire)

Trial Locations

Locations (1)

Hospital Universitario Puerta de Hierro Majadahonda; 🇪🇸 Madrid, Spain