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:
2025-12-26 @ 11:07 AM
Ignite Modification Date:
2025-12-26 @ 11:07 AM
NCT ID:
NCT05543512
Eligibility Criteria:
Inclusion Criteria:
In order to be eligible to participate in this study, an individual must meet all of the following criteria:
* Age: 16 - 80 years
* Diagnosis of EoE as per consensus guidelines
* No prior treatment with, or documented failure of, dietary elimination therapy. Failure is defined as =\>15 eos/hpf after a course of the six-food elimination diet (SFED).
* On stable diet for 4 weeks prior to screening endoscopy and agree to maintain throughout course of participation. Foods eliminated for allergic or other reactions are not exclusionary and may continue to be avoided throughout participation in the study regardless of food trigger results.
In addition to meeting the above criteria, to be eligible for randomization an individual must meet all of the following criteria:
* Active EoE (=\>15 eos/hpf) based on clinical biopsies taken during baseline endoscopy
* Must have at least one positive food on the IgG4 or T cell stimulation assay
Exclusion Criteria:
* Concomitant eosinophilic gastritis and/or enteritis, confirmed with a prior clinicohistologic diagnosis
* Use of systemic corticosteroids within 4 weeks of the baseline/qualifying endoscopic exam
* Previous esophageal resection
* History of bleeding disorder or esophageal varices
* Current use of blood thinners such as coumadin, warfarin, heparin, and/or novel anticoagulant agents (requires discontinuation of medication within an appropriate time frame for that specific agent and in accordance with standard clinical practice)
* Medical instability that precludes safely performing upper endoscopy
* Inability to read or understand English
* Pregnancy or breastfeeding
* Body mass index (BMI) \<17
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Maximum Age:
80 Years
Study:
NCT05543512
Study Brief:
Protocol Section:
NCT05543512