Esophageal String Test Monitoring to Monitor Eosinophilic Esophagitis During Oral Immunotherapy

NCT06389994 | Recruiting

• 1 other identifier: 23-021041
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Eosinophilic Esophagitis (EoE)

Outcome Measures

Primary Outcomes (1)

• Esophageal String Test

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

  baseline, 3 month and 6 months

Secondary Outcomes (2)

• Prevalence of Eosinophilic Esophagitis

  Baseline, 3 month and 6 months

• Eosinophilic Esophagitis Symptoms

  Baseline, 3 month and 6 months

Study Arms (1)

Patients undergoing oral immunotherapy

All patients will have esophageal string test

Device: Esophageal String Test

Interventions

Esophageal String Test DEVICE

The EnteroTracker® capsule is supplied in pouches, each pouch containing a single capsule. The device is comprised of an ingestible capsule that contains a weighted ball and a highly absorbent nylon string. The looped portion of the string is secured externally to the patient's cheek and the rest of the capsule is swallowed by the patient.

Also known as: EnteroTracker®

Patients undergoing oral immunotherapy

Eligibility Criteria

• Age: 7 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children 7 years of age or older with IgE mediated food allergy undergoing OIT at Children's Hospital of Philadelphia (CHOP) will be enrolled in this study. Prior work at CHOP and other pediatric centers has demonstrated that most children 7 years and older can swallow EST capsules. Subjects will be identified by reviewing the Electronic Medical Record of IgE-mediated food allergy patients scheduled for evaluation in CHOP Allergy Clinic OIT clinic. Informed consent and assent will be obtained.

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.

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead

Study Sites (1)

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

MeSH Terms

Conditions

Eosinophilic Esophagitis

Condition Hierarchy (Ancestors)

Esophagitis; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Gastroenteritis; Eosinophilia; Leukocyte Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Jonathan M Spergel, MD, PhD

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sharon A Carbonara, MS, BSN, RN

CONTACT

267.426.8603; carbonara@chop.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatrics; Chief, Allergy Section Director of Center for Pediatric Eosinophilic Disease

Study Record Dates

• First Submitted: April 19, 2024
• First Posted: April 29, 2024
• Study Start: April 1, 2024
• Primary Completion: April 2, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: May 29, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)