EoE Food Test Pilot Study

March 12, 2026 updated by: Children's Hospital of Philadelphia

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

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?

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: David A Hill, MD, PhD
  • Phone Number: 215-300-0985
  • Email: hilld3@chop.edu

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • The Children's Hospital of Philadelphia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Diagnosis of Eosinophilic esophagitis (EoE) based on positive esophageal biopsy (>15 eosinophils/high power field) within three months of enrollment.

AND Intention to undergo dietary intervention for treatment of their EoE. AND Unknown contribution of one or more of milk, soy, egg, and wheat to their EoE disease state.

AND Willingness to adopt an elimination diet based in part on the results of the experimental testing.

Exclusion Criteria:

Proton pump inhibitor (PPI)-responsive EoE: Resolution or response of EoE to high-dose PPI (2 mg/kg) alone, at the PI's discretion.

OR Presence of other inflammatory or infectious gastrointestinal pathology (e.g. eosinophilic gastrointestinal diseases, irritable bowel disease, Infectious Colitis, etc.), at the discretion of the Principal Investigator (PI).

OR Prior medical or surgical history that precludes safely performing an upper endoscopy with biopsy or restriction of diet.

OR Current immunomodulatory therapy >4 weeks (swallowed or systemic steroids, biologic therapy, chemotherapy. etc.) that may interfere with the blood test or biopsy results, at the PI's discretion.

OR Inability to read or understand English.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Esophageal eosinophilia (number of eosinophils in the esophagus)
Time Frame: At least 4 weeks after implementation of diet changes
Eosinophils per high power field on follow up esophageal biopsy
At least 4 weeks after implementation of diet changes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pediatric Eosinophilic Esophagitis Symptom Score (total score based on pediatric symptom score)
Time Frame: At least 4 weeks after implementation of diet changes
Min 0-Max 100 (lower is better)
At least 4 weeks after implementation of diet changes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Hospital of Philadelphia

Collaborators

Food Allergy Fund
American Partnership for Eosinophilic Disorders

Investigators

  • Principal Investigator: David A Hill, MD, PhD, Children's Hospital of Philadelphia, University of Pennsylvania

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2027

Primary Completion (Estimated)

January 1, 2029

Study Completion (Estimated)

January 1, 2029

Study Registration Dates

First Submitted

June 10, 2025

First Submitted That Met QC Criteria

June 10, 2025

First Posted (Actual)

June 17, 2025

Study Record Updates

Last Update Posted (Actual)

March 16, 2026

Last Update Submitted That Met QC Criteria

March 12, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 24-022349

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is no plan to share individual participant data with other researchers. All data that may be published or shared with other researchers will be deidentified and will not include information such as informed consent forms.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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