Prospective Multicenter Nationwide Registry of Children With Eosinophilic Esophagitis

Study Overview
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Brief Summary
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Registry of demographic, clinical, endoscopic and histological data at baseline. 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 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 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

Official Title
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Prospective Multicenter Nationwide Registry of Children With Eosinophilic Esophagitis

Conditions
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Eosinophilic Esophagitis

Intervention / Treatment
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* Other: no intervention


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 1 Month
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Children with eosinophilic esophagitis<br>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). | Other: no intervention<br>* no intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete histological remission | Complete histological remission response defined as ≤5 eosinophils/hpf in all biopsies performed | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Partial histological remission | Partial histological remission response defined as 5-15 eosinophils /hpf in all biopsies | 12 weeks | 
| Clinical remission | Clinical remission (specific questionnaire) | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Eosinophilic Esophagitis; PPIs, children, elimination diet, topical steroids