Esophageal String Test Monitoring to Monitor Eosinophilic Esophagitis During Oral Immunotherapy

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age7-17
SponsorChildren's Hospital of Philadelphia

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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.

Treatment groups

75 Participants
are divided into 1 treatment group
Group A: Patients undergoing oral immunotherapy1 intervention

Trial outcomes

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

Time frame
baseline, 3 month and 6 months

Secondary outcomes

1

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

Time frame
Baseline, 3 month and 6 months
2

Eosinophilic Esophagitis Symptoms

EOE symptoms will be measured by Pediatric Eosinophilic Esophagitis Symptom Score. HIgher score indicates more symptoms. Range is zero to 72

Time frame
Baseline, 3 month and 6 months

Other outcomes

Sponsors and contacts

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