NCT07023380

EoE Food Test Pilot Study

Pilot Interventional Study of an EoE-Causal Food Identification Blood Test

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Children's Hospital of Philadelphia · Academic / Other
• Sex: All
• Age: 0 Years – 90 Years
• Healthy volunteers: Not accepted

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?

Detailed description

This proof-of-concept, interventional prospective cohort study will enroll subjects with Eosinophilic esophagitis (EoE) who have not yet identified causal foods. Subject blood will be drawn and food-activated T cell responses will be assayed. Subjects will be advised to remove foods based on standard-of-care practices and/or the outcome of their T cell assays ("personalized elimination diet"). Symptoms will be measured by the Pediatric Eosinophilic Esophagitis Symptom Scores (PEESS) Child and Parent Surveys and standard of care (SOC) endoscopy with esophageal biopsy, respectively. Response to research assay-directed diet changes will provide information about the assay's clinical value.

Conditions

• Eosinophilic Esophagitis Caused by Food (Disorder)

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2027-01-01
• Primary completion: 2029-01-01
• Completion: 2029-01-01
• First posted: 2025-06-17
• Last updated: 2026-03-16

Locations

1 site across 1 country: United States