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Esophageal String Test Monitoring for Eosinophilic Esophagitis During Oral Immunotherapy

This study is looking at a new way to check for Eosinophilic Esophagitis (EoE), an allergic condition of the esophagus (food pipe), in children and teens who have food allergies and are starting oral immunotherapy (OIT). OIT is a treatment where you eat small, increasing amounts of a food you're allergic to. The study will use a device called the Esophageal String Test (EnteroTracker® capsule), which involves swallowing a capsule with a string attached. This test helps doctors see if EoE is developing. Researchers will compare the results of this test with a symptom questionnaire. You can join if you are 7-17 years old, have a history of IgE-mediated food allergy, are considering OIT at CHOP, and can swallow the capsule. The study aims to see how well the Esophageal String Test works as a screening tool.

Study design
This is an observational study involving 75 participants aged 7-17 years old. It is not a randomized or blinded study.
What's involved
You would have the Esophageal String Test and complete a symptom questionnaire at the start of OIT, and then again at 3 and 6 months into your OIT treatment.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 6 months after starting oral immunotherapy.

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NCT06389994

Esophageal String Test Monitoring to Monitor Eosinophilic Esophagitis During Oral Immunotherapy

Recruiting
Not specifiedAges 7–17Observational
Children's Hospital of Philadelphia
~75 participants
Updated 2025-05-29 on ClinicalTrials.gov
What's tested:Esophageal String Test

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Esophageal String Test
Measured over baseline, 3 month and 6 months

Conditions

Eosinophilic Esophagitis (EoE)

Explore related trials

Eosinophilic Esophagitis

Where it's being run

1 sites across 1 states
Pennsylvania1

Study leadership

  • Jonathan M Spergel, MD, PhD · PRINCIPAL_INVESTIGATOR · Children's Hospital of Philadelphia

Who to contact

Sharon A Carbonara, MS, BSN, RN
[email protected]
267.426.8603
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Esophageal String Testbaseline, 3 month and 6 months

    Esophageal String Test (EST) will measure presence of eosinophilic protein. Higher score is more eosinophils.. Range is 0 to 100