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Search / Trial NCT07023380

EoE Food Test Pilot Interventional Study

Launched by CHILDREN'S HOSPITAL OF PHILADELPHIA · Jun 10, 2025

Trial Information

Current as of June 27, 2025

Not yet recruiting

Keywords

ClinConnect Summary

This clinical trial is studying a new, simple blood test that aims to help identify which foods cause a condition called Eosinophilic Esophagitis (EoE), an allergic inflammation of the esophagus triggered by certain foods. The goal is to see if this blood test, when used alongside standard care like endoscopies (a procedure where a small camera looks inside the esophagus), can accurately predict food allergies that worsen EoE. This could make it easier to figure out which foods to avoid without relying solely on more invasive tests.

People who might be eligible for this study include anyone diagnosed with EoE confirmed by a recent biopsy (a small tissue sample from the esophagus), who plan to try changing their diet to manage their condition. Specifically, the study focuses on those who don’t yet know if milk, soy, egg, or wheat are causing their symptoms and who are willing to follow a diet that removes certain foods based partly on the new test results. Participants can expect to have blood tests and possibly endoscopies as part of the study, and they will work with their doctors to adjust their diet accordingly. It’s important to know that people whose EoE improves with certain medications or who have other gut problems might not be eligible. The study is not yet recruiting, but it includes people of all ages and genders.

Gender

ALL

Eligibility criteria

  • 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.

About Children's Hospital Of Philadelphia

The Children's Hospital of Philadelphia (CHOP) is a leading pediatric healthcare institution renowned for its commitment to advancing child health through innovative research and clinical care. As a prominent clinical trial sponsor, CHOP emphasizes a multidisciplinary approach to pediatric research, fostering collaborations across various specialties to develop and evaluate groundbreaking therapies and interventions. With a focus on improving patient outcomes and enhancing the quality of life for children, CHOP is dedicated to conducting rigorous clinical trials that adhere to the highest ethical standards and scientific integrity, ultimately contributing to the global knowledge base in pediatric medicine.

Locations

Philadelphia, Pennsylvania, United States

Patients applied

0 patients applied

Trial Officials

David A Hill, MD, PhD

Principal Investigator

Children's Hospital of Philadelphia, University of Pennsylvania

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported