Esophageal String Test Monitoring to Monitor Eosinophilic Esophagitis During Oral Immunotherapy
Recruiting now
Conditions studied: Eosinophilic Esophagitis (EoE)
In brief
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.
Key facts
- Study ID
- NCT06389994
- Run by
- Children's Hospital of Philadelphia
- People needed
- 75
- Starts
- 2024-04-01
- Expected to finish
- 2026-10-01
- Last updated by the study team
- 2025-05-29
Who can join
Age: 7 and older, up to 17. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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 is running
- The Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States (enrolling)
Full record on ClinicalTrials.gov
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