Esophageal String Test Monitoring to Monitor Eosinophilic Esophagitis During Oral Immunotherapy

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
Children's Hospital of Philadelphia
Study ID
NCT06389994
Status
Recruiting
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Conditions

  • Eosinophilic Esophagitis (EoE)

Eligibility Criteria

Sex
ALL
Age
7 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • Esophageal String Test — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Apr 1, 2024
Status verified
May 2025
Primary completion
Apr 2, 2026
Completion
Oct 1, 2026

Study Design

Enrollment
75 participants (estimated)

Arms

  • Arm: Patients undergoing oral immunotherapy
    All patients will have esophageal string test

Primary Outcome Measure

Esophageal String Test [ Time Frame: baseline, 3 month and 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The Children's Hospital of PhiladelphiaPhiladelphiaPennsylvania19104
Sharon A Carbonara, MS, BSN, RN
[email protected]
267.426.8603

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By research site
The Children's Hospital of Philadelphia· Philadelphia, PA

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