NCT06389994

Esophageal String Test Monitoring to Monitor Eosinophilic Esophagitis During Oral Immunotherapy

Monitoring Eosinophilic Esophagitis During Food Oral Immunotherapy Using Esophageal String Test

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 75 (estimated)
• Sponsor: Children's Hospital of Philadelphia · Academic / Other
• Sex: All
• Age: 7 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Detailed 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 prevalence of EoE in IgE mediated food allergy patients, which Investigators will measure at the time of presentation for OIT, (3) provide an estimate of the incidence of development of EoE during the first 3- and 6- months of OIT. The study will take place at the Children's Hospital of Philadelphia Food Allergy Clinic sites that participate in OIT. There will be 75 participants ages 7-18 years of age with IgE mediated food allergy who are undergoing oral immunotherapy for food allergies.

Conditions

• Eosinophilic Esophagitis (EoE)

Interventions

Type	Name	Description
DEVICE	Esophageal 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.

Timeline

• Start date: 2024-04-01
• Primary completion: 2026-04-02
• Completion: 2026-10-01
• First posted: 2024-04-29
• Last updated: 2025-05-29

Locations

1 site across 1 country: United States