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 @ 12:04 AM
Ignite Modification Date:
2025-12-25 @ 12:04 AM
NCT ID:
NCT02019758
Eligibility Criteria:
Inclusion criteria are as follows:
* Age: 16 - 80 years
* Subject is having a clinically indicated endoscopy for suspicious EoE and has been on twice daily (BID) proton pump inhibitor (PPI) for at least 8 weeks OR New diagnosis of EoE as per consensus guidelines. Cases must have symptoms of dysphagia, persistent esophageal eosinophilia (≥ 15 eosinophils in at least one high-power field) after 8 weeks of treatment with a twice daily proton-pump inhibitor, and other competing causes of esophageal eosinophilia excluded.
Exclusion criteria are as follows:
* Medical instability that precludes safely performing upper endoscopy
* Ongoing or recent symptoms of intestinal bleeding (throwing up blood, passing blood in the stool)
* Concomitant eosinophilic gastroenteritis
* Esophageal narrowing or stricturing that will not allow a standard 9 mm upper endoscopy scope to pass
* Cancer in the esophagus, stomach, or intestine
* Previous esophageal surgery
* Esophageal varices (dilated blood vessels in the esophagus)
* Current use of blood thinners like Plavix or Coumadin that are not stopped prior to endoscopy procedures
* Any corticosteroid exposure within the 4 weeks prior to their baseline endoscopic exam. Exclusionary corticosteroid exposure is defined as any swallowed topical steroids for EoE or systemic steroids for any condition within the four weeks prior to the baseline endoscopy. Corticosteroids used for asthma or intranasal corticosteroids are not an exclusion and are allowable.
* Pregnancy
* Inability to read or understand English
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Maximum Age:
80 Years
Study:
NCT02019758
Study Brief:
Protocol Section:
NCT02019758