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 @ 12:37 AM
Ignite Modification Date:
2025-12-25 @ 12:37 AM
NCT ID:
NCT02778867
Eligibility Criteria:
Inclusion Criteria:
* Have diagnosis of EoE (based on consensus criteria)
* Have histologically confirmed active disease \>15 eosinophils/hpf in either distal or proximal esophagus within 12 weeks of screening visit
* Symptomatic (have experienced symptoms within the last month prior to enrollment)
* Proton pump inhibitor (PPI) confirmation
* Have a negative urine pregnancy test at screening if of childbearing potential
Exclusion Criteria:
* Have been treated with topical swallowed steroids within the last 2 months or systemic steroids within the last 3 months
* Have pathological eosinophilia in segments of the GI tract other than the esophagus determined by local review
* Have been diagnosed with a GI malabsorption disorder (i.e., Inflammatory bowel disease, Crohn's disease) or Celiac disease
* Are currently on dietary therapy strictly avoiding milk or on a 6FED
* Have concurrent H pylori gastritis or parasitic infection
* Have history of anaphylaxis to milk (with current avoidance of milk)
* Have previously failed strict dietary therapy clearly documented with one of these regimens or topical steroid treatment (i.e. have achieved histological remission of \<15 eos/hpf after having been on fluticasone or \>1mg budesonide per day).
* Use of investigational drugs within 4 weeks (one month) prior to enrollment
* Are concurrently receiving any of the prohibited medications for the study
* On immunotherapy for pollen (if not on maintenance therapy) or immunoglobulin-E (IgE) -mediated food allergy
* Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT02778867
Study Brief:
Protocol Section:
NCT02778867