Clinical trial NCT07023380: EoE Food Test Pilot Interventional Study
Official title: Pilot Interventional Study of an EoE-Causal Food Identification Blood Test
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Eosinophilic Esophagitis Caused by Food (Disorder)
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
Collaborators: name: Food Allergy Fund
name: American Partnership for Eosinophilic Disorders
First posted: 2025-06-17
Enrollment: 50
Sex: ALL
Minimum age (years): 0
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This pilot 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. Test results will be provided to subjects physician(s) to be used in conjunction with standard-of-care practices when determining which foods should be removed from the subject's diet. Symptoms and inflammation will be measured by PEESS Child and Parent Surveys and standard of care (SOC) endoscopy with esophageal biopsy, respectively. Response to research assay-aided diet changes will provide information about the assay's clinical value in a "real-world" setting.
Primary purpose: DIAGNOSTIC

Brief 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?

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.

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.

Primary outcomes:
measure: Esophageal eosinophilia (number of eosinophils in the esophagus)
timeFrame: At least 4 weeks after implementation of diet changes
Secondary outcomes:
measure: Pediatric Eosinophilic Esophagitis Symptom Score (total score based on pediatric symptom score)
timeFrame: At least 4 weeks after implementation of diet changes
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: The Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Children's Hospital of Philadelphia, University of Pennsylvania
name: David A Hill, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hill DA, Spergel JM. The Immunologic Mechanisms of Eosinophilic Esophagitis. Curr Allergy Asthma Rep. 2016 Feb;16(2):9. doi: 10.1007/s11882-015-0592-3.
citation: De Vlieger L, Smolders L, Nuyttens L, Verelst S, Breynaert C, Vanuytsel T, Hoffman I, Bullens DM. A Clinical Perspective on the Dietary Therapies for Pediatric Eosinophilic Esophagitis: The Gap Between Research and Daily Practice. Front Immunol. 2021 May 19;12:677859. doi: 10.3389/fimmu.2021.677859. eCollection 2021.
citation: Nhu QM, Aceves SS. Tissue Remodeling in Chronic Eosinophilic Esophageal Inflammation: Parallels in Asthma and Therapeutic Perspectives. Front Med (Lausanne). 2017 Aug 7;4:128. doi: 10.3389/fmed.2017.00128. eCollection 2017.
citation: Spergel JM, Brown-Whitehorn TF, Cianferoni A, Shuker M, Wang ML, Verma R, Liacouras CA. Identification of causative foods in children with eosinophilic esophagitis treated with an elimination diet. J Allergy Clin Immunol. 2012 Aug;130(2):461-7.e5. doi: 10.1016/j.jaci.2012.05.021. Epub 2012 Jun 27.
citation: Dellon ES, Rusin S, Gebhart JH, Covey S, Higgins LL, Beitia R, Speck O, Woodward K, Woosley JT, Shaheen NJ. Utility of a Noninvasive Serum Biomarker Panel for Diagnosis and Monitoring of Eosinophilic Esophagitis: A Prospective Study. Am J Gastroenterol. 2015 Jun;110(6):821-7. doi: 10.1038/ajg.2015.57. Epub 2015 Mar 17.
citation: Dilollo J, Rodriguez-Lopez EM, Wilkey L, Martin EK, Spergel JM, Hill DA. Peripheral markers of allergen-specific immune activation predict clinical allergy in eosinophilic esophagitis. Allergy. 2021 Nov;76(11):3470-3478. doi: 10.1111/all.14854. Epub 2021 May 14.