Characteristics and Inflammatory Markers in Children With Eosinophilic Esophagitis (EoE)

Eosinophilic Esophagitis Clinical Trial

— EoE  

Official title:

Characteristics and Inflammatory Markers in Children With Eosinophilic Esophagitis (EoE)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03980886
• Other study ID #: 181690
• Secondary ID: 1K24AI135034-015
• Status: Recruiting
• Start date: February 11, 2019
• Est. completion date: December 17, 2028

Study information

• Verified date: May 2023
• Source: University of California, San Diego
• Contact: Kira Chaiboonma, BS
• Phone: 8589661700
• Email: kchaiboonma[@]health.ucsd.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Single center observational and specimen banking study for children with eosinophilic esophagitis EoE to gauge natural history and inflammatory markers

Description:

Participants with a diagnosis of EoE are recruited from Rady Children's Hospital Eosinophilic Gastrointestinal Disorders (EGID) during routine clinic and/or endoscopy visits.

Medical information including clinical symptoms, endoscopy, histopathology, medical and surgical history, lab and imaging findings, are entered into a UCSD database at each clinic or endoscopy visit. Blood and biopsy specimens are procured and utilized for analysis of inflammatory molecules and for isolation of structural cells. This protocol continues our clinical database and sample collection in children with EoE. The database provides a cohort of EoE patients for studies of natural history, therapeutic response, and disease progression. In a relatively new disease of increasing incidence, these studies will provide information on disease progression and the clinical characteristics of patients who have varying disease phenotypes as well as the associations between clinical phenotypes, molecular changes, and disease course. The procurement and storage of tissue, cells, and serum samples provides a repository for studies of EoE-related molecules and peripheral markers in clinically phenotyped patients. In addition, the study of these esophageal cells will provide an in vitro model system for assessing the molecular mechanisms of disease pathogenesis in EoE.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1200
• Est. completion date: December 17, 2028
• Est. primary completion date: December 17, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 65 Years

Eligibility

Inclusion Criteria:

• Have a known EoE diagnosis

• Complain of dysphagia, vomiting, or abdominal pain, especially if recalcitrant to acid blocking therapy (but does not have to be recalcitrant to acid blocking medications)

• Present with food impaction

• Present with esophageal stricture

• Have characteristic endoscopic findings of EoE of pallor, linear furrows, lichenification, white plaques, or concentric rings

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Eosinophilic Esophagitis
• Esophagitis

Locations

Country	Name	City	State
United States	Rady Children's Hospital San Diego	San Diego	California

Sponsors (3)

Lead Sponsor	Collaborator
University of California, San Diego	National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The longitudinal trajectory of symptoms, endoscopy, and histology in pediatric EoE during routine clinical care	Outcome measures of symptoms, histology, endoscopy, and lab values such as peripheral eosinophilia and cortisol procured at each clinical and/or endoscopy visit will be entered and tracked in a UCSD/RCHSD de-identified database in order to understand their longitudinal trajectory during routine clinical care	10 years
Primary	The longitudinal trajectory of inflammatory markers in blood and biopsies in pediatric EoE during routine clinical care	The presence and severity of inflammatory markers and cells over time in specimens collected during routine endoscopy and biopsy will be measured to understand their alignment with outcome measures of symptoms, histology, and endoscopy	10 years