EoE Food Test Pilot Study
NCT07023380 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50
Last updated 2026-03-16
Summary
The objective of this study is to determine the performance characteristics of a series of novel, non-invasive allergen-activated T cell assays designed to identify Eosinophilic esophagitis (EoE) causal foods, when used in conjunction with standard-of-care (SOC) practices.
The question it aims to answer is:
Will assay results accurately predict EoE food allergies in concordance with SOC endoscopies after diet changes?
Conditions
- Eosinophilic Esophagitis Caused by Food (Disorder)
Interventions
- DIAGNOSTIC_TEST
-
Assay directed diet change
Functional T cell assay(s) will be performed on research subjects' peripheral blood using four foods known to commonly cause Eosinophilic esophagitis - milk, soy, egg, and wheat. Response magnitude to foods in vitro will influence whether a subject's physician chooses to recommend the subject AVOID the food or continue to CONSUME the food. Disease response to the diet changes will be evaluated in standard-of-care follow up endoscopy.
Sponsors & Collaborators
-
Food Allergy Fund
collaborator UNKNOWN -
American Partnership for Eosinophilic Disorders
collaborator UNKNOWN -
Children's Hospital of Philadelphia
lead OTHER
Principal Investigators
-
David A Hill, MD, PhD · Children's Hospital of Philadelphia, University of Pennsylvania
Study Design
- Allocation
- NA
- Purpose
- DIAGNOSTIC
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 0 Years
- Max Age
- 90 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2027-01-01
- Primary Completion
- 2029-01-01
- Completion
- 2029-01-01
Countries
- United States
Study Locations
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