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

University of California San Diego logo

University of California San Diego

Status

Enrolling

Conditions

Eosinophilic Esophagitis

Study type

Observational

Funder types

Other
NIH

Identifiers

NCT03980886
2R01DK114457 (U.S. NIH Grant/Contract)
2R56AI092135 (U.S. NIH Grant/Contract)
181690

Details and patient eligibility

About

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

Full 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.

Enrollment

1,500 estimated patients

Sex

All

Ages

1 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

1

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Central trial contact

Seema S Aceves, MD, PhD; Kira Chaiboonma, BS

Data sourced from clinicaltrials.gov

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