Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:07 PM
Ignite Modification Date:
2025-12-24 @ 5:07 PM
NCT ID:
NCT03615950
Eligibility Criteria:
Inclusion Criteria:
* Intervention:
1. Age 5-12 years
2. Diagnosis of EoE based upon a peak eosinophil count of ≥ 15 eosinophils/high powered field (hpf) on at least one esophageal biopsy while on a minimum of 8 weeks of PPI therapy
3. Patient/Family has elected to start swallowed corticosteroids for the treatment of EoE with a minimum daily dose of at least 0.5 mg budesonide or 440 mcg fluticasone. The decision to start swallowed corticosteroids will be made based upon the judgement of the provider, potential subject, and family during a clinic visit and will not be part of the research procedures.
* Controls:
1. Age 5-12 years
2. Followed in the ACH allergy clinic, but not required to have a diagnosis of EoE
3. Not treated with swallowed corticosteroids
Exclusion Criteria:
* Intervention and controls:
1. Non-English speaking
2. Patients actively taking systemic corticosteroids or previous use of systemic corticosteroids within the past 6 months
3. Patients actively taking inhaled corticosteroids or prior use of inhaled corticosteroids in the 6 months prior to screening
4. Current or previous treatment with swallowed corticosteroids for EoE at the time of screening
5. Osteopenia or osteoporosis on baseline dual energy X-ray absorptiometry (DEXA).
Sex:
ALL
Minimum Age:
5 Years
Maximum Age:
12 Years
Study:
NCT03615950
Study Brief:
Protocol Section:
NCT03615950