Actively Recruiting

Age: 7Years - 17Years
All Genders
NCT06389994

Esophageal String Test Monitoring to Monitor Eosinophilic Esophagitis During Oral Immunotherapy

Led by Children's Hospital of Philadelphia · Updated on 2025-05-29

75

Participants Needed

1

Research Sites

130 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Esophageal String Test Monitoring to Monitor Eosinophilic Esophagitis During Oral Immunotherapy

Who Can Participate

Age: 7Years - 17Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female, aged 7 to 18 years old, inclusive
  • History of Immunoglobulin (IgE)-mediated food allergy
  • Considering oral immunotherapy (OIT) for food allergies at Children's Hospital of Philadelphia
  • Able and willing to swallow the esophageal capsule
  • Parental or guardian permission and child assent if appropriate
  • Willing to comply with all study procedures and available for the study duration
Not Eligible

You will not qualify if you...

  • Known or expected need for MRI imaging during the study period
  • Known connective tissue disease
  • Known eosinophilic disorder including eosinophilic gastrointestinal disorder and hypereosinophilic disorder
  • Past history of caustic ingestion or esophageal injury
  • History of esophageal surgery or dilation
  • History of gastrointestinal motility disorder including esophageal achalasia
  • History of inflammatory bowel disease
  • Unwilling or unable to swallow the Esophageal String Test
  • Oral or intravenous steroids in the past 60 days (excluding swallowed topical steroids)
  • Participation in another clinical study that may interfere
  • Pregnant or lactating females
  • Limited English proficiency
  • Considered potentially non-compliant by the Investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States, 19104

Actively Recruiting

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Research Team

S

Sharon A Carbonara, MS, BSN, RN

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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Esophageal String Test Monitoring to Monitor Eosinophilic Esophagitis During Oral Immunotherapy | DecenTrialz