Ignite Creation Date:
2024-05-06 @ 8:26 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06389994
Status:
RECRUITING
Last Update Posted:
2024-04-30
First Post:
2024-04-19
Brief Title:
Esophageal String Test Monitoring to Monitor Eosinophilic Esophagitis During Oral Immunotherapy
Sponsor:
Childrens Hospital of Philadelphia
Organization:
Childrens Hospital of Philadelphia
Study Overview
Official Title:
Monitoring Eosinophilic Esophagitis During Food Oral Immunotherapy Using Esophageal String Test
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 v20 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 objectives 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 Childrens 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
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 objectives 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 Childrens 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None