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 @ 11:17 PM
Ignite Modification Date:
2025-12-24 @ 11:17 PM
NCT ID:
NCT05695456
Eligibility Criteria:
Inclusion Criteria:
* Eosinophilic Esophagitis, with peak eosinophil count of \>15 eos/HPF and symptoms of dysphagia at least 2 days per week
* Patients have had a trial of high-dose PPI for at least 8 weeks, with either documented non-response or intolerance to the medication
* Patients aged between 18 and 70 years old
* Signed written informed consent
* Eosinophilic Esophagitis, with peak eosinophil count of \>15 eos/HPF and symptoms of dysphagia at least 2 days per week
* Patients have had a trial of high-dose PPI for at least 8 weeks, with either documented non-response or intolerance to the medication
* Patients aged between 18 and 70 years old
* Signed written informed consent
Exclusion criteria:
* IgE-mediated food anaphylaxis for 1 of the trigger nutrients
* History of major gastrointestinal surgery complicating esophago-gastro-duodenoscopy
* Gastro-esophageal reflux disease (GERD) Los Angeles grade C or D
* Esophageal strictures, too narrow to pass with a normal gastroscope
* Endoscopic dilation in the esophagus in the 4 weeks prior to inclusion
* Celiac disease
* Recent use (within two weeks) of non-steroidal anti-inflammatory drugs (NSAIDs), systemic histamine-receptor antagonists, mast cell stabilizers, opioids.
* Proton pump inhibitors must be either stopped for at least 4 weeks, or continued on a stable dosage throughout the study period.
* Corticosteroids should be stopped for at least 4 weeks.
* Allergy to fluorescein, Xylocain or Propofol
* Pregnant or lactating women
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT05695456
Study Brief:
Protocol Section:
NCT05695456