Monitoring Eosinophilic Esophagitis During Food Oral Immunotherapy Using Esophageal String Test
Children's Hospital of Philadelphia
Summary
Patients with IgE mediated food Allergy have elevated risk of eosinophilic esophagitis, and new therapies like oral immunotherapy (OIT) carry additional risk of Eosinophilic Esophagitis (EoE). The goal of this study is to investigate the Esophageal String Test (EST) as a screening tool for Eosinophilic Esophagitis (EoE) during OIT therapy. Investigators will compare the efficacy of the Esophageal String Test to symptom assessment using a validated patient reported symptom questionnaire, the Pediatric Eosinophilic Esophagitis Symptom Score (PEESS) v2.0. Investigators will utilize these tools to screen patients at their baseline visit prior to the start of OIT, then at the 3- and 6-month OIT follow-up visits.
Description
The goal of this study is to investigate the EST as a screening tool for EoE during OIT therapy. Investigators will utilize these tools to screen patients at their baseline visit prior to the start of OIT, then at the 3- and 6-month OIT follow-up visits. The primary objectives are to assess feasibility of the EST as a screening tool for EoE in IgE mediated food allergy patients in an OIT program. The secondary objective(s) are to: (1) estimate the correlation of EST and PEESS in screening for EoE in IgE mediated food allergy patients in an OIT program, (2) provide an estimate of the prevalen…
Eligibility
- Age range
- 7–17 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: An individual must meet all of the following criteria: * Male or female, aged 7 to 18 years old, inclusive * Have a history of Immunoglobulin (IgE)-mediated food allergy * Considering using oral immunotherapy (OIT) for food allergies at CHOP° * Able \& willing to swallow the esophageal capsule * Parental/guardian permission (informed consent) and if appropriate, child assent. * Willing to comply with all study procedures and be available for the duration of the study. Exclusion Criteria: * Known or expected need for MRI imaging during the study period * Known connective…
Interventions
- DeviceEsophageal String Test
The EnteroTracker® capsule is supplied in pouches, each pouch containing a single capsule. The device is comprised of an ingestible capsule that contains a weighted ball and a highly absorbent nylon string. The looped portion of the string is secured externally to the patient's cheek and the rest of the capsule is swallowed by the patient.
Location
- The Children's Hospital of PhiladelphiaPhiladelphia, Pennsylvania