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NCT Number: NCT06389994

Esophageal String Test Monitoring to Monitor Eosinophilic Esophagitis During Oral Immunotherapy

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.

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Key information

Age range

7 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location status: Recruiting

Location contact

Sharon A Carbonara, MS, BSN, RN

CONTACT

[email protected]

267.426.8603

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: EnteroTracker®

Primary outcomes

  1. Esophageal String Test

    Time frame: baseline, 3 month and 6 months

    Esophageal String Test (EST) will measure presence of eosinophilic protein. Higher score is more eosinophils.. Range is 0 to 100

Secondary outcomes

  1. Prevalence of Eosinophilic Esophagitis

    Time frame: Baseline, 3 month and 6 months

    EOE will be determined by the upper endoscopy showing greater than 15 eos/hpf. Normal is zero. Range is from 0 to 100

  2. Eosinophilic Esophagitis Symptoms

    Time frame: Baseline, 3 month and 6 months

    EOE symptoms will be measured by Pediatric Eosinophilic Esophagitis Symptom Score.

    HIgher score indicates more symptoms. Range is zero to 72

Study contacts

Contact information is provided by the study sponsor or research team.

Sharon A Carbonara, MS, BSN, RN

CONTACT

[email protected]

267.426.8603

Sponsors and collaborators

Lead sponsor

Children's Hospital of Philadelphia

Other

Registry information

Official study title

Monitoring Eosinophilic Esophagitis During Food Oral Immunotherapy Using Esophageal String Test

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Apr 29, 2024
Registry last updated
May 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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