EoE Food Test Pilot Study
Starting soon · Not applicable
Conditions studied: Eosinophilic Esophagitis Caused by Food (Disorder)
In brief
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 facts
- Study ID
- NCT07023380
- Run by
- Children's Hospital of Philadelphia
- People needed
- 50
- Starts
- 2027-01-01
- Expected to finish
- 2029-01-01
- Last updated by the study team
- 2026-03-16
Who can join
Age: any, up to 90. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- The Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
Full record on ClinicalTrials.gov
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