RECRUITING

Esophageal String Test Monitoring to Monitor Eosinophilic Esophagitis During Oral Immunotherapy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Monitoring Eosinophilic Esophagitis During Food Oral Immunotherapy Using Esophageal String Test

Quick Facts

Study Start:2024-04-01

Study Completion:2026-10-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06389994

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:7 Years to 17 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Study Contact

Sharon A Carbonara, MS, BSN, RN

CONTACT

267.426.8603

carbonara@chop.edu

Principal Investigator

Jonathan M Spergel, MD, PhD

PRINCIPAL_INVESTIGATOR

Children's Hospital of Philadelphia

Study Locations (Sites)

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104

United States

Collaborators and Investigators

Sponsor: Children's Hospital of Philadelphia

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-04-01

Study Completion Date2026-10-01

Study Record Updates

Study Start Date2024-04-01

Study Completion Date2026-10-01

Terms related to this study

Additional Relevant MeSH Terms

Eosinophilic Esophagitis (EoE)