ClinicalTrials.gg
RecruitingNCT06389994Updated May 29, 2025

Esophageal String Test Monitoring to Monitor Eosinophilic Esophagitis During Oral Immunotherapy

An observational study in Eosinophilic Esophagitis (EoE), sponsored by Children's Hospital of Philadelphia. Recruiting at 1 site in United States. Open to participants aged 7 Years to 17 Years. Per ClinicalTrials.gov, last updated 2025-05-29.

Sponsored by Children's Hospital of Philadelphia · Observational

From the registry’s dates

  • Primary completion was expected by Apr 2026, 7 months ago, but the record still lists the study as recruiting.
  • Started Apr 2024; still recruiting 2 years 7 months later.

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Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
75
Ages
7 Years to 17 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 165 studies in Eosinophilic Esophagitis with a site in United States — 23 open to participants now, 41 under way, 3 of them phase 3. Eosinophilic Esophagitis · United States.

Planned enrollment
28th of 53
75 · median 80
Started
2024
with 5 others
Observational
53 of 165
13 open now
Primary completion
2026-04
later than 9 of 40 live
Registered
148th of 165
by date
Lead sponsor
5 of 165
Children's Hospital of Philadelphia

Among the 165 studies in Eosinophilic Esophagitis with a site in United States, this one is the 28th largest by planned enrollment of the 53 observational ones that give a count, is one of 6 that started in 2024, is one of 53 observational ones, reaches primary completion later than 9 of the 40 other live ones, and was the 148th registered.

Eosinophilic Esophagitis

235 studies on the registry are indexed under Eosinophilic Esophagitis; 53 are open to participants now.

Browse Eosinophilic Esophagitis studies →

Open to participants now

23 of the 165 studies in Eosinophilic Esophagitis with a site in United States are open now. Recruiting first, the newest first:

17 more — sign in →

All 23 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 42 Eosinophilic Esophagitis studies recruiting now, 12 (29%) set no upper age limit and 27 (64%) stop at 75 or younger; 27 take children under 18; 7 take healthy volunteers.

This study: 7 Years to 17 Years · all sexes · no healthy volunteers.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 165 studies in Eosinophilic Esophagitis with a site in United States, or all of them as a file.
02

Study 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.

Read the detailed 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.

03

Conditions studied

  • Eosinophilic Esophagitis (EoE)
04

Who can participate

Ages eligible
7 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study 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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 () and if appropriate, child assent.
  • Willing to comply with all study procedures and be available for the duration of the study.

Exclusion criteria

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 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.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
75 participants (estimated)
Patient registry
No

Groups and cohorts

  • Patients undergoing oral immunotherapy

    All patients will have esophageal string test

    Device: Esophageal String Test

Interventions

  • DeviceEsophageal 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.

    Also known as: EnteroTracker®

06

What researchers measure

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

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No — There is no plan to share individual participant data (IPD) available to other researchers.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Apr 2024 (actual). Primary completion is estimated for Apr 2026, 24 months after the start.

Of 52 non-industry observational studies under Eosinophilic Esophagitis, half reached primary completion within 49 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 120. This study's planned 24 months is below that.

Counting every sponsor, half of 55 studies reached it within 49 months; a quarter within 22 and three quarters within 120.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 19, 2024
First posted
Apr 29, 2024
StartActual
Apr 1, 2024
Primary completionEst.
Apr 2, 2026
CompletionEst.
Oct 1, 2026
Last update
May 29, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 29, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06389994
Responsible party
Jonathan Spergel (Professor of Pediatrics; Chief, Allergy Section Director of Center for Pediatric Eosinophilic Disease, Children's Hospital of Philadelphia) — Principal investigator
First posted
Apr 29, 2024
Start date
Apr 1, 2024
Primary completion
Apr 2, 2026 (estimated)
Completion
Oct 1, 2026 (estimated)
Last update
May 29, 2025

Study contacts

Sharon A Carbonara, MS, BSN, RN
Contact
carbonara@chop.edu
267.426.8603
Jonathan M Spergel, MD, PhD
principal investigator · Children's Hospital of Philadelphia

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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