75 Participants Needed

Esophageal String Test Monitoring to Monitor Eosinophilic Esophagitis During Oral Immunotherapy

SA
Overseen BySharon A Carbonara, MS, BSN, RN
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: Children's Hospital of Philadelphia
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of 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.

Who Is on the Research Team?

JM

Jonathan M Spergel, MD, PhD

Principal Investigator

Children's Hospital of Philadelphia

Are You a Good Fit for This Trial?

Inclusion Criteria

I am currently receiving oral immunotherapy for food allergies at CHOP.
I have a history of severe food allergies.
I can and will swallow the esophageal capsule.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Baseline Assessment

Baseline assessment using the Esophageal String Test and PEESS questionnaire before starting OIT

1 week
1 visit (in-person)

Treatment

Participants undergo oral immunotherapy with monitoring using the Esophageal String Test and PEESS at 3 and 6 months

6 months
2 visits (in-person) at 3 and 6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Patients undergoing oral immunotherapyExperimental Treatment1 Intervention
All patients will have esophageal string test

Find a Clinic Near You

Who Is Running the Clinical Trial?

Children's Hospital of Philadelphia

Lead Sponsor

Trials
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Recruited
11,400,000+
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