|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
12 December 2020 |
|
Main ID: |
NCT01846962 |
|
Date of registration:
|
30/04/2013 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Dietetic Versus Topical Steroids for Pediatric Eosinophilic Esophagitis
|
|
Scientific title:
|
COMPARISON OF TREATMENT FOR PEDIATRIC EOSINOPHILIC ESOPHAGITIS: A RANDOMIZED CLINICAL TRIAL (DIETETIC Versus TOPICAL STEROIDS) |
|
Date of first enrolment:
|
November 2012 |
|
Target sample size:
|
64 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT01846962 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
|
|
Phase:
|
Phase 4
|
|
|
Countries of recruitment
|
|
Italy
| | | | | | | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- suspected, or previously diagnosed, EoE in phase of clinical activity.
Diagnostic criteria were:
1. suggestive esophageal symptoms (GERD-like disease, dysphagia, food impaction);
2. 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;
3. 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 Criteria:
- diagnosis of concomitant inflammatory, rheumatic or infectious disease,
- and the assumption of any dietetic or therapy since the clinical onset.
Age minimum:
6 Months
Age maximum:
18 Years
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Eosinophilic Esophagitis
|
|
Intervention(s)
|
|
Behavioral: six-foods elimination diet
|
|
Drug: Budesonide
|
|
Drug: Oral Viscous Budesonide (OVB)
|
|
Drug: Fluticasone
|
|
Primary Outcome(s)
|
|
Efficacy Clinical Severity Score
[Time Frame: 3 months]
|
|
Secondary Outcome(s)
|
|
Efficacy Severity Score for Endoscopy and Histology
[Time Frame: 3 months]
|
|
Secondary ID(s)
|
|
Pediatric-EoE
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|