Esophageal String Test Monitoring to Monitor Eosinophilic Esophagitis During Oral Immunotherapy

NCT ID: NCT06389994

Last Updated: 2025-05-29

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 75 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-04-01
• Study Completion Date: 2026-10-01

Brief 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)

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients undergoing oral immunotherapy

All patients will have esophageal string test

Esophageal String Test

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

EnteroTracker®

Eligibility Criteria

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 tissue disease
• Known eosinophilic disorder including any eosinophilic gastrointestinal disorder and hypereosinophilic disorder
• Past history of caustic ingestion or other esophageal injury
• History of esophageal surgery or dilation (i.e.: tracheoesophageal fistula repair)
• History of gastrointestinal motility disorder including esophageal achalasia
• History of inflammatory bowel disease
• Unwilling or unable to swallow the EST
• Oral or intravenous steroids in the preceding 60 days (not including swallowed topical fluticasone, budesonide, etc.)
• Participation in a clinical study that may interfere with participation in this study
• Pregnant or lactating females
• Limited English proficiency
• Parents/guardians or subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Children's Hospital of Philadelphia

OTHER

Sponsor Role: lead

Responsible Party

Jonathan Spergel

Professor of Pediatrics; Chief, Allergy Section Director of Center for Pediatric Eosinophilic Disease

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jonathan M Spergel, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital of Philadelphia

Locations

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Sharon A Carbonara, MS, BSN, RN

Role: CONTACT

carbonara@chop.edu

267.426.8603

Facility Contacts

Sharon A Carbonara, MS, BSN, RN

Role: primary

carbonara@chop.edu

267.426.8603

Other Identifiers

23-021041

Identifier Type: -

Identifier Source: org_study_id