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:
2025-12-25 @ 4:53 AM
Ignite Modification Date:
2025-12-25 @ 4:53 AM
NCT ID:
NCT01458418
Eligibility Criteria:
Inclusion Criteria:
* Males and females aged 2-17
* Presence of more than 15 eosinophils per hpf on original endoscopy and less than 5 eosinophils/hpf on the most recent endoscopy
* Concurrent PPI for 1 month at 1-2mg/kg/dose prior to endoscopy or have a negative pH study
* English speaking
* Ability to undergo a follow up endoscopy between 12 and 13 weeks after the start of the study
* Procurement of written informed consent signed by the subject's legal guardian and study investigator (s) and subject assent.
Exclusion Criteria:
* Subjects with eosinophils in stomach and duodenum on original endoscopy.
* Subjects requiring oral prednisone within 1 month of current endoscopy.
* Subjects with diagnosis of other co-morbid diseases such as heart disease, renal disease, autoimmune disease, an immunodeficiency, diabetes, phenylketonuria, or thyroid disease.
* Subjects using Montelukast within one month of current endoscopy
* Subjects with concurrent use of phenobarbital or rifampin
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Years
Maximum Age:
17 Years
Study:
NCT01458418
Study Brief:
Protocol Section:
NCT01458418