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 @ 5:38 PM
Ignite Modification Date:
2025-12-24 @ 5:38 PM
NCT ID:
NCT05342168
Eligibility Criteria:
Inclusion Criteria:
* Previous histologic diagnosis of eosinophilic esophagitis (symptoms of esophageal dysfunction and at least 15 eosinophils per high-power field on esophageal biopsy and after a comprehensive assessment of non-EoE disorders that could cause or potentially contribute to esophageal eosinophilia).1
* Capable of swallowing a capsule 3 cm in length (trial with 3 cm jelly candy).
* 10 to 18 years of age.
* Male or female.
* Able to give assent or consent.
* Scheduled for an upper gastrointestinal endoscopy with biopsies on the same day to assess response to therapy and make decisions regarding further management.
Exclusion Criteria:
* Unable to swallow the capsule.
* Unable to give assent or consent.
* History of esophageal stricture on either upper gastrointestinal barium study or previous upper gastrointestinal endoscopy of food impaction that required removal.
* History of portal hypertension or esophageal varices.
* History of solid organ transplantation.
* Known bleeding diathesis.
* On anticoagulation therapy.
* Known platelet count less than normal for age.
* Pregnancy.
* Need for intubation during endoscopy.
* History of previous esophageal surgery.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
10 Years
Maximum Age:
18 Years
Study:
NCT05342168
Study Brief:
Protocol Section:
NCT05342168