Esophageal String Test Monitoring to Monitor Eosinophilic Esophagitis During Oral Immunotherapy

Recruiting

• Conditions: Eosinophilic Esophagitis (EoE)
• Interventions: Device: Esophageal String Test

• Registration Number: NCT06389994
• Lead Sponsor: Children's Hospital of Philadelphia

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.

Detailed Description

The goal of this study is to investigate the EST as a screening tool for EoE during OIT therapy. 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.

The primary objectives are to assess feasibility of the EST as a screening tool for EoE in IgE mediated food allergy patients in an OIT program.

The secondary objective(s) are to: (1) estimate the correlation of EST and PEESS in screening for EoE in IgE mediated food allergy patients in an OIT program, (2) provide an estimate of the prevalence of EoE in IgE mediated food allergy patients, which Investigators will measure at the time of presentation for OIT, (3) provide an estimate of the incidence of development of EoE during the first 3- and 6- months of OIT.

The study will take place at the Children's Hospital of Philadelphia Food Allergy Clinic sites that participate in OIT. There will be 75 participants ages 7-18 years of age with IgE mediated food allergy who are undergoing oral immunotherapy for food allergies.

Study Timeline

• Status Verified: 2024-04
• Study Start: 2024-04-01
• Study First Submitted: 2024-04-19
• Study First Submitted QC: 2024-04-25
• Study First Posted: 2024-04-29
• Last Update Submitted: 2024-04-29
• Last Update Posted: 2024-04-30
• Primary Completion: 2026-04-02
• Study Completion: 2026-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 75

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
• Undergoing 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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients undergoing oral immunotherapy	Esophageal String Test	All patients will have esophageal string test

Primary Outcome Measures

Name	Time	Method
Esophageal String Test	baseline, 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

Secondary Outcome Measures

Name	Time	Method
Prevalence of Eosinophilic Esophagitis	Baseline, 3 month and 6 months	EOE will be determined by the upper endoscopy showing greater than 15 eos/hpf. Normal is zero. Range is from 0 to 100
Eosinophilic Esophagitis Symptoms	Baseline, 3 month and 6 months	EOE symptoms will be measured by Pediatric Eosinophilic Esophagitis Symptom Score.; HIgher score indicates more symptoms. Range is zero to 72

Trial Locations

Locations (1)

The Children's Hospital of Philadelphia; 🇺🇸 Philadelphia, Pennsylvania, United States