N/A
N=24
Application of a Novel Allergen-Specific Immune Signature Directed Approach to Dietary Elimination Therapy in Patients With Eosinophilic Esophagitis (IDiET)
Eosinophilic Esophagitis
Bottom Line
View on ClinicalTrials.gov: NCT02722148 ↗Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Apr 2019
Primary outcome: Primary: Percentage of Histologic Responders — 21 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Novel Allergen-Specific Immune Signature Directed Approach to Dietary Elimination Therapy (Device)
- Age
- Pediatric, Adult, Older Adult · 16+ yrs
- Sex
- All
- Sponsor
- University of North Carolina, Chapel Hill
- Primary completion
- Apr 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Histologic Responders |
21 | — |
| SECONDARY Median Peak Esophageal Eosinophil Count |
35 | — |
| SECONDARY Endoscopy Score |
3.0 | — |
| SECONDARY Dysphagia Symptom Score |
25.0 | — |
Summary
This is a prospective single center clinical trial of allergen-specific immune signature-guided dietary elimination therapy to assess the clinical effectiveness of this technique.
Eligibility Criteria
Inclusion Criteria
- Age 16-80 years old
- Meet one of the following:
- Active EoE as per consensus guidelines OR
- Undergoing upper endoscopy for a clinical suspicion of EoE
- No prior history of dietary elimination therapy
Exclusion Criteria
- Concomitant eosinophilic gastroenteritis
- Any corticosteroid exposure in the 4 weeks prior to their baseline endoscopic exam
- Previous esophageal surgery
- Medical instability that precludes safely performing upper endoscopy
- Inability to read or understand English
- Pregnant women
Data sourced from ClinicalTrials.gov (NCT02722148). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.