Eosinophilic Esophagitis (EoE)NCT06389994
Esophageal String Test Monitoring to Monitor Eosinophilic Esophagitis During Oral Immunotherapy
An observational study of Eosinophilic Esophagitis (EoE), run by Children's Hospital of Philadelphia at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 7 to 17 years
- Conditions the study is for
- Eosinophilic Esophagitis (EoE)
- What is being tested?
- Esophageal String Test
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2024to 1 Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 17 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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.
Who cannot join
- 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
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Sharon A Carbonara, MS, BSN, RN, 267.426.8603, carbonara@chop.edu
About this study
Official title: Monitoring Eosinophilic Esophagitis During Food Oral Immunotherapy Using Esophageal String Test
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.
- Conditions
- Eosinophilic Esophagitis (EoE)
- Being tested
- Esophageal String Test
- Medical subject headings
- Eosinophilic Esophagitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Esophageal String TestDevice
Also called EnteroTracker®
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing oral immunotherapy | All patients will have esophageal string test Receives: Device: Esophageal String Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Esophageal String Test
Esophageal String Test (EST) will measure presence of eosinophilic protein. Higher score is more eosinophils.. Range is 0 to 100
Measured: baseline, 3 month and 6 months
Secondary outcomes (2)
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
Measured: Baseline, 3 month and 6 months
Eosinophilic Esophagitis Symptoms
EOE symptoms will be measured by Pediatric Eosinophilic Esophagitis Symptom Score.
HIgher score indicates more symptoms. Range is zero to 72
Measured: Baseline, 3 month and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2024
- Study start1 Apr 2024
- Primary completion2 Apr 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eosinophilic Esophagitis (EoE)Studies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jonathan Spergel, Children's Hospital of Philadelphia
- Investigators
- Jonathan M Spergel, MD, PhD, Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06389994
- Sponsor's protocol ID
- 23-021041
- Status last verified
- May 2025
- First submitted
- 19 Apr 2024
- Last updated
- 29 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share individual participant data (IPD) available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring Eosinophilic Esophagitis During Food Oral Immunotherapy Using Esophageal String Test
- ClinicalTrials.gov ID
- NCT06389994
- Acronym / sponsor ID
- 23-021041
- Conditions
- Eosinophilic Esophagitis (EoE)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 2 Apr 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 29 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing oral immunotherapy | – | Device: Esophageal String TestAll patients will have esophageal string test |
Who may qualify
- Ages
- 7 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (13 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Esophageal String TestAlso: EnteroTracker®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. | Device | Patients undergoing oral immunotherapy |
Primary outcome
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
2 secondary outcomes
Prevalence of Eosinophilic Esophagitis
Time frame: Baseline, 3 month and 6 months
Eosinophilic Esophagitis Symptoms
Time frame: Baseline, 3 month and 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2025.
- Individual participant dataSharing planned: No. There is no plan to share individual participant data (IPD) available to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jonathan M Spergel, MD, PhD principal investigator
Children's Hospital of Philadelphia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Eosinophilic Esophagitis (EoE), run by Children's Hospital of Philadelphia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sharon A Carbonara, MS, BSN, RN (267.426.8603, carbonara@chop.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Esophageal String Test (time frame: baseline, 3 month and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2025.