EoE Food Test Pilot Study

Conditions

• Eosinophilic Esophagitis Caused by Food (Disorder)

Eligibility Criteria

Sex

ALL

Age

0 Years - 90 Years

Healthy Volunteers

Not accepted

Interventions

• Assay directed diet change — DIAGNOSTIC_TEST
  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.

Study Details

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?

Key Dates

Start date

Jan 1, 2027

Status verified

Mar 2026

Primary completion

Jan 1, 2029

Completion

Jan 1, 2029

Study Design

Enrollment

50 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Arms

• Experimental: EoE unknown
  Patients with Eosinophilic esophagitis who have not yet identified their disease causal foods and are interested in an elimination diet approach to disease management

Primary Outcome Measure

Esophageal eosinophilia (number of eosinophils in the esophagus) [ Time Frame: At least 4 weeks after implementation of diet changes ]

Central Contacts

• David A Hill, MD, PhD
  215-300-0985
  [email protected]

Locations (1)

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