Status:
COMPLETED
Dietetic Versus Topical Steroids for Pediatric Eosinophilic Esophagitis
Lead Sponsor:
Azienda Policlinico Umberto I
Conditions:
Eosinophilic Esophagitis
Eligibility:
All Genders
6-18 years
Phase:
PHASE4
Brief Summary
Therapeutic strategies for eosinophilic esophagitis (EoE) actually include: 1) allergen avoidance through dietary modifications, and 2) pharmacologic antiinflammatory therapy. Medical treatment is mai...
Detailed Description
Eosinophilic esophagitis (EoE) is characterized by significant eosinophilic infiltration of esophageal mucosa, leading to tissue damage and consequently to esophageal symptoms. The clinical presentati...
Eligibility Criteria
Inclusion
- \- suspected, or previously diagnosed, EoE in phase of clinical activity.
- Diagnostic criteria were:
- suggestive esophageal symptoms (GERD-like disease, dysphagia, food impaction);
- a negative 24 hours pH-impedenzometric study or, whether positive, the refractoriness to a high dose proton pump inhibitor (PPI) therapy for at least 8 weeks;
- the histological demonstration of \>15/20 eosinophils/HPF on at least 1 esophageal biopsy. Patients who received any dietetic or antiinflammatory treatment in the last 6 months were dropped out, and no allergy therapy was allowed during the study
Exclusion
- diagnosis of concomitant inflammatory, rheumatic or infectious disease,
- and the assumption of any dietetic or therapy since the clinical onset.
Key Trial Info
Start Date :
November 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT01846962
Start Date
November 1 2012
End Date
June 1 2013
Last Update
May 11 2018
Active Locations (1)
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1
Departments of Pediatrics, Sapienza - University of Rome
Rome, Italy, 00161