Monitoring Eosinophilic Esophagitis During Food Oral Immunotherapy Using Esophageal String Test

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 7
Maximum Age: 17
Healthy Volunteers: f
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⁃ 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.

Locations
United States
Pennsylvania
The Children's Hospital of Philadelphia
RECRUITING
Philadelphia
Contact Information
Primary
Sharon A Carbonara, MS, BSN, RN
carbonara@chop.edu
267.426.8603
Time Frame
Start Date: 2024-04-01
Estimated Completion Date: 2026-10-01
Participants
Target number of participants: 75
Treatments
Patients undergoing oral immunotherapy
All patients will have esophageal string test
Sponsors
Leads: Children's Hospital of Philadelphia

This content was sourced from clinicaltrials.gov