FARE - Food Allergy Research & Education Logo

Esophageal String Test Monitoring to Monitor Eosinophilic Esophagitis During Oral Immunotherapy

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 7 Years - 17 Years
Gender All
More Inclusion & Exclusion Criteria

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.
  • - Undergoing 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06389994
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Children's Hospital of Philadelphia
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Jonathan M Spergel, MD, PhD
Principal Investigator Affiliation Children's Hospital of Philadelphia
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Eosinophilic Esophagitis (EoE)
Additional Details

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.

Arms & Interventions

Arms

: Patients undergoing oral immunotherapy

All patients will have esophageal string test

Interventions

Device: - Esophageal 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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

The Children's Hospital of Philadelphia, Philadelphia, Pennsylvania

Status

Recruiting

Address

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104

Site Contact

Sharon A Carbonara, MS, BSN, RN

[email protected]

267-426-8603

The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation.