About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial 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.
Trial design
Cohort
Prospective
Treatments tested in this trial
Esophageal String Test
DeviceThe 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.
Treatment groups
Trial outcomes
Primary outcomes
Esophageal String Test
Esophageal String Test (EST) will measure presence of eosinophilic protein. Higher score is more eosinophils.. Range is 0 to 100
Secondary outcomes
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
Eosinophilic Esophagitis Symptoms
EOE symptoms will be measured by Pediatric Eosinophilic Esophagitis Symptom Score. HIgher score indicates more symptoms. Range is zero to 72
Sponsors and contacts
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