Eosinophilic Esophagitis Caused by Food (Disorder)
Conditions
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.
Interventions
DIAGNOSTIC_TESTAssay directed diet change
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.
Sponsors
Children's Hospital of Philadelphia
Food Allergy Fund
American Partnership for Eosinophilic Disorders
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
0 Years to 90 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Esophageal eosinophilia (number of eosinophils in the esophagus) | At least 4 weeks after implementation of diet changes | Eosinophils per high power field on follow up esophageal biopsy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pediatric Eosinophilic Esophagitis Symptom Score (total score based on pediatric symptom score) | At least 4 weeks after implementation of diet changes | Min 0-Max 100 (lower is better) |
Countries
United States
Contacts
CONTACTDavid A Hill, MD, PhD
PRINCIPAL_INVESTIGATORDavid A Hill, MD, PhD
Children's Hospital of Philadelphia, University of Pennsylvania
Outcome results
None listed