Prospective Multicenter Nationwide Registry of Children With Eosinophilic Esophagitis
NCT ID: NCT03858426
Last Updated: 2019-02-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
500 participants
OBSERVATIONAL
2019-01-01
2022-07-30
Brief Summary
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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
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Children with eosinophilic esophagitis
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).
no intervention
no intervention
Interventions
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no intervention
no intervention
Eligibility Criteria
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Inclusion Criteria
* 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
* Simultaneous treatment with more than one treatment modality (PPI, empirical elimination diet, swallowed corticosteroids).
1 Month
18 Years
ALL
No
Sponsors
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Sociedad Espanola de Gastroenterologia, Hepatologia y Nutricion Pediatrica
OTHER
Responsible Party
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Carolina Gutierrez Junquera
Principal Investigator
Locations
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Hospital Universitario Puerta de Hierro Majadahonda
Madrid, , Spain
Countries
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Central Contacts
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Facility Contacts
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Carolina Gutierrez Junquera, PhD
Role: primary
Other Identifiers
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RENESE
Identifier Type: -
Identifier Source: org_study_id