Spontaneous study on the efficacy and safety of an oral viscous suspension of budesonide administered to children affected by eosinophilic esophagitis.

Phase 1

• Conditions: Eosinophilic Esophagitis; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2014-002465-30-IT
• Lead Sponsor: Dip. Pediatria UOC Gastroenterologia ed Epatologia Pediatrica

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-06-24
• Last Update Posted: 2 October 2017

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

patients of both gender aged below 18 yrs with diagnosis of eosinophilic esophagitis verified by histological examination of esophageal biopsies (eosinophil count >/= 15/HPF)
Newly diagnosed patients or previously put under restricted diet or treated with fluticasone/budesonide nebulizer suspension with negative results or relapse.

Are the trial subjects under 18? yes
Number of subjects for this age range: 30
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Age > 18 yrs
Patients with concomitant crhonic intestinal pathologies, heart or gut, respiratory or kidney malformations , neurological deficit, uncertain diagnosis of Eosinophilic Esophagitis

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: evaluate the efficacy of budesoniode treatment, a viscous oral suspension, in patiens affected with Eosinophilic Esophagitis, in whom other type of therapies have failed or patients with relapse, or newly diagnosed patients. Evaluate treatment safety in terms of adverse reactions or impact on the cortical-adrenal activity.;Secondary Objective: Not Applicable;Primary end point(s): Decrease of eosinophilic infiltration, evaluated by biopsy at 0, 12 and 36 (follow-up) weeks.;Timepoint(s) of evaluation of this end point: 0, 12 and 36 (follow-up) week

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Not Applicable;Timepoint(s) of evaluation of this end point: Not Applicable