Recruiting

Esophageal String Test

Sponsor:

Children's Hospital of Philadelphia

Code:

NCT06389994

Conditions

Eosinophilic Esophagitis (EoE)

Eligibility Criteria

Sex: All

Age: 7 - 17

Healthy Volunteers: Not accepted

Interventions

Esophageal String Test

Study Details

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.

Conditions

Eosinophilic Esophagitis (EoE)

Study ID

NCT06389994

Start date

Apr 1, 2024

Status verified date

May, 2025

Completion date

Oct 1, 2026

Anticipated

Primary completion date

Apr 2, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 7 - 17

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

75 participants

Anticipated

Interventions and Outcome Measures

Arms

Patients undergoing oral immunotherapy

All patients will have esophageal string test

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Sharon A Carbonara, MS, BSN, RN

267.426.8603carbonara@chop.edu

Locations

The Children's Hospital of Philadelphia

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Sharon A Carbonara, MS, BSN, RN

267.426.8603carbonara@chop.edu

More Information

Sponsor

Children's Hospital of Philadelphia

Last update posted

May 29, 2025

Last verified

May, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Children's Hospital of Philadelphia on 2025-05-29.