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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03980886
Acronym
EoE
Enrollment
1500
Registered
2019-06-10
Start date
2019-02-11
Completion date
2028-12-17
Last updated
2026-07-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Eosinophilic Esophagitis

Brief summary

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

Detailed 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.

Interventions

None listed

Sponsors

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

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
The longitudinal trajectory of symptoms, endoscopy, and histology in pediatric EoE during routine clinical care10 yearsOutcome 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
The longitudinal trajectory of inflammatory markers in blood and biopsies in pediatric EoE during routine clinical care10 yearsThe 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

Countries

United States

Contacts

CONTACTAngie Rodriguez Verdin, BS
anrodriguezverdin@health.ucsd.edu8589661700
CONTACTSeema S Aceves, MD, PhD
saceves@ucsd.edu8585342983

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 8, 2026