Esophageal String Test Monitoring to Monitor Eosinophilic Esophagitis During Oral Immunotherapy

Eosinophilic Esophagitis (EoE) Clinical Trial

Official title:

Monitoring Eosinophilic Esophagitis During Food Oral Immunotherapy Using Esophageal String Test

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06389994
• Other study ID #: 23-021041
• Status: Recruiting
• Start date: April 1, 2024
• Est. completion date: October 1, 2026

Study information

• Verified date: April 2024
• Source: Children's Hospital of Philadelphia
• Contact: Sharon A Carbonara, MS, BSN, RN
• Phone: 267.426.8603
• Email: carbonara[@]chop.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: October 1, 2026
• Est. primary completion date: April 2, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 17 Years

Eligibility

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.

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.

Related Conditions & MeSH terms

• Eosinophilic Esophagitis
• Eosinophilic Esophagitis (EoE)
• Esophagitis

Intervention

Device:
• Esophageal String Test
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.

Locations

Country	Name	City	State
United States	The Children's Hospital of Philadelphia	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital of Philadelphia

Country where clinical trial is conducted

United States, 

Outcome

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