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NCT Number: NCT07023380

EoE Food Test Pilot Study

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?

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Key information

Age range

0 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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)

Study contacts

Contact information is provided by the study sponsor or research team.

David A Hill, MD, PhD

CONTACT

[email protected]

215-300-0985

Sponsors and collaborators

Lead sponsor

Children's Hospital of Philadelphia

Other

Collaborators

  • American Partnership for Eosinophilic Disorders
  • Food Allergy Fund

Registry information

Official study title

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

Important dates

Study start
2027
Primary completion
2029
Study completion
2029
First posted
Jun 17, 2025
Registry last updated
Mar 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.