Not Yet RecruitingNot Applicable

EoE Food Test Pilot Study

United States50 participantsStarted 2027-01-01

Plain-language 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?

Who can participate

Age range

0 Years – 90 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Esophageal eosinophilia (number of eosinophils in the esophagus)

Timeframe: At least 4 weeks after implementation of diet changes

Trial details

NCT IDNCT07023380

SponsorChildren's Hospital of Philadelphia

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2029-01-01

Contact for this trial

David A Hill, MD, PhD

215-300-0985 hilld3@chop.edu

View on ClinicalTrials.gov More Eosinophilic Esophagitis Caused by Food (Disorder) trials