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 @ 1:38 AM
Ignite Modification Date:
2025-12-25 @ 1:38 AM
NCT ID:
NCT06389994
Eligibility Criteria:
Inclusion Criteria:
An individual must meet all of the following criteria:
* Male or female, aged 7 to 18 years old, inclusive
* Have a history of Immunoglobulin (IgE)-mediated food allergy
* Considering using oral immunotherapy (OIT) for food allergies at CHOP°
* Able \& willing to swallow the esophageal capsule
* Parental/guardian permission (informed consent) and if appropriate, child assent.
* Willing to comply with all study procedures and be available for the duration of the study.
Exclusion Criteria:
* Known or expected need for MRI imaging during the study period
* Known connective tissue disease
* Known eosinophilic disorder including any eosinophilic gastrointestinal disorder and hypereosinophilic disorder
* Past history of caustic ingestion or other esophageal injury
* History of esophageal surgery or dilation (i.e.: tracheoesophageal fistula repair)
* History of gastrointestinal motility disorder including esophageal achalasia
* History of inflammatory bowel disease
* Unwilling or unable to swallow the EST
* Oral or intravenous steroids in the preceding 60 days (not including swallowed topical fluticasone, budesonide, etc.)
* Participation in a clinical study that may interfere with participation in this study
* Pregnant or lactating females
* Limited English proficiency
* Parents/guardians or subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
7 Years
Maximum Age:
17 Years
Study:
NCT06389994
Study Brief:
Protocol Section:
NCT06389994