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| Name | Class |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
| Office of Rare Diseases (ORD) | NIH |
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The purpose of this study is to test the effectiveness of utilizing Transnasal Esophagoscopy as a means of monitoring Eosinophilic Esophagitis patients.
A participant with an established diagnosis of EoE who is undergoing Standard of Care treatment with a four or less food elimination diet (not including or counting foods restricted at time of EoE diagnosis) OR is on topical swallowed steroid therapy with any number of foods eliminated from the diet, is in histological remission, and has been recommended as part of Standard of Care to start a single new food introduction OR remove the swallowed steroid treatment by the subject's clinical allergist or gastroenterologist will be enrolled in the study. 14-17 days after the introduction of the clinically recommended single food antigen, a TNE will be performed to assess the esophageal mucosa. TNE will be performed every 2 weeks for six weeks (3 total TNE) to evaluate recurrence time of mucosal eosinophilia (>15 eos/HPF), other histological changes, and patient tolerance to serial TNE. At week 6 a sedated esophagoscopy will be offered as an alternative choice to TNE if the participant chooses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Phase | Other | Treatment Phase will evaluate the effectiveness of Transnasal Esophagoscopy (TNE) as an acceptable form of monitoring Eosinophilic Esophagitis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transnasal esophagoscopy | Other | single food antigen introduction OR removal of topical swallowed steroid therapy followed by surveillance utilizing TNE |
|
| Measure | Description | Time Frame |
|---|---|---|
| Histological Improvement | To prospectively and serially evaluate the recurrence of esophageal eosinophilia (>15 eosinophils per high power field) after a clinical single food antigen introduction OR removal of swallowed topical steroid therapy by the subject's clinical allergist or gastroenterologist in children with EoE using unsedated Transnasal Endoscopy/Esophagoscopy. | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Endoscopic Appearances/Histological Findings | 1. To identify serially the clinical (endoscopic appearances) and other histological findings (lamina propria fibrosis, mast cells, lymphocytes) associated with dietary food introductions OR swallowed topical steroid therapy removal in children with EoE. | 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joel Friedlander, M.D. | Children's Hospital Colorado | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital Colorado | Denver | Colorado | 80218 | United States |
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| Label | URL |
|---|---|
| Related info | View source |
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| National Center for Advancing Translational Sciences (NCATS) |
| NIH |
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| Sample Size |
2. To determine and evaluate mucosal sample size obtained during TNE (2.0 mm or 1.2 mm forceps) compared to that obtained during those same subjects' previous traditional sedated endoscopy/esophagoscopy (2.8 mm forceps). |
| 6 weeks |
| Decision to participate | 3. To assess family factors determining decision to complete TNE study and subject's satisfaction with serial TNE using the previously reported TNE Qualitative Questionnaire, the General Anxiety Disorder (GAD)-7 Anxiety Instrument and a structured interview. | 6 weeks |
| ID | Term |
|---|---|
| D057765 | Eosinophilic Esophagitis |
| ID | Term |
|---|---|
| D004941 | Esophagitis |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D005759 | Gastroenteritis |
| D004802 | Eosinophilia |
| D007960 | Leukocyte Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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