Monitoring Eosinophilic Esophagitis During Oral Immunotherapy with a String Test
Monitoring Eosinophilic Esophagitis During Food Oral Immunotherapy Using Esophageal String Test
This study is testing if a new string test can help find Eosinophilic Esophagitis in kids with food allergies who are getting treatment to help them tolerate those foods.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 75 (estimated) |
| Ages | 7 Years to 17 Years |
| Sex | All |
| Sponsor | Children's Hospital of Philadelphia Academic / other |
| Drugs / interventions | immunotherapy |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Trial ID | NCT06389994 on ClinicalTrials.gov |
What this trial studies
This study investigates the use of the Esophageal String Test (EST) as a screening tool for Eosinophilic Esophagitis (EoE) in patients with IgE-mediated food allergies undergoing oral immunotherapy (OIT). Participants will be screened at baseline and followed up at 3 and 6 months to assess the feasibility of the EST compared to symptom assessments using the Pediatric Eosinophilic Esophagitis Symptom Score (PEESS) v2.0. The study aims to estimate the prevalence and incidence of EoE in this patient population during OIT therapy.
Who should consider this trial
Good fit: Ideal candidates are children aged 7 to 18 years with a history of IgE-mediated food allergies who are considering OIT.
Not a fit: Patients with known eosinophilic disorders or gastrointestinal motility issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a reliable screening method for EoE in patients undergoing OIT, improving patient management and outcomes.
How similar studies have performed: While the use of the Esophageal String Test is a novel approach in this context, similar studies have shown promise in utilizing non-invasive screening methods for gastrointestinal conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
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 * 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. 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.
Where this trial is running
Philadelphia, Pennsylvania
- The Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Jonathan M Spergel, MD, PhD — Children's Hospital of Philadelphia
- Study coordinator: Sharon A Carbonara, MS, BSN, RN
- Email: carbonara@chop.edu
- Phone: 267.426.8603
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.