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| Name | Class |
|---|---|
| Food Allergy Fund | UNKNOWN |
| American Partnership for Eosinophilic Disorders | UNKNOWN |
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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?
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EoE unknown | Experimental | Patients with Eosinophilic esophagitis who have not yet identified their disease causal foods and are interested in an elimination diet approach to disease management |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Esophageal eosinophilia (number of eosinophils in the esophagus) | Eosinophils per high power field on follow up esophageal biopsy | At least 4 weeks after implementation of diet changes |
| Measure | Description | Time Frame |
|---|---|---|
| Pediatric Eosinophilic Esophagitis Symptom Score (total score based on pediatric symptom score) | Min 0-Max 100 (lower is better) | At least 4 weeks after implementation of diet changes |
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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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| David A Hill, MD, PhD | Contact | 215-300-0985 | hilld3@chop.edu |
| Name | Affiliation | Role |
|---|---|---|
| David A Hill, MD, PhD | Children's Hospital of Philadelphia, University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26758862 | Background | 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. | |
| 34093578 | Background | 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. |
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There is no plan to share individual participant data with other researchers. All data that may be published or shared with other researchers will be deidentified and will not include information such as informed consent forms.
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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.
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| 28831387 | Background | 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. |
| 22743304 | Background | 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. |
| 25781367 | Background | 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. |
| 33840099 | Background | 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. |