Monitoring Eosinophilic Esophagitis During Oral Immunotherapy with a String Test

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the use of the Esophageal String Test (EST) as a screening tool for Eosinophilic Esophagitis (EoE) in patients with IgE-mediated food allergies undergoing oral immunotherapy (OIT). Participants will be screened at baseline and followed up at 3 and 6 months to assess the feasibility of the EST compared to symptom assessments using the Pediatric Eosinophilic Esophagitis Symptom Score (PEESS) v2.0. The study aims to estimate the prevalence and incidence of EoE in this patient population during OIT therapy.

Why it matters

Who can join: the full rules

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.

Where it's running

• The Children's Hospital of Philadelphia
  Philadelphia, Pennsylvania, United States Recruiting

Study contacts

• Principal investigator: Jonathan M Spergel, MD, PhD — Children's Hospital of Philadelphia
• Study coordinator: Sharon A Carbonara, MS, BSN, RN
• Email: carbonara@chop.edu
• Phone: 267.426.8603

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.