Characteristics and Inflammatory Markers in Children With... | NCT03980886

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

NCT03980886

Sponsor

University of California, San Diego

Status

Recruiting

Last Update Posted

Jul 7, 2026Actual

Enrollment

1,500Estimated

Phase

Not provided

Conditions

Eosinophilic Esophagitis

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2R01DK114457	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Jun 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 11, 2019Actual

Primary Completion Date

Dec 17, 2028Estimated

Completion Date

Dec 17, 2028Estimated

First Submitted Date

Apr 23, 2019

First Submission Date that Met QC Criteria

Jun 7, 2019

First Posted Date

Jun 10, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 2, 2026

Last Update Posted Date

Jul 7, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Seema Aceves, Professor, Pediatrics and Medicine, University of California, San DiegoPrincipal Investigator

Lead Sponsor

University of California, San DiegoOTHER

Collaborators

Name	Class
National Institutes of Health (NIH)	NIH
National Institute of Allergy and Infectious Diseases (NIAID)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

1,500Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Year

Maximum Age

65 Years

Standard Ages

ChildAdultOlder Adult

Study Population

The majority of patients who are diagnosed with EoE or suspected EoE at RCHSD/UCSD

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Angie Rodriguez Verdin, BS	Contact	8589661700	225005	anrodriguezverdin@health.ucsd.edu
Seema S Aceves, MD, PhD	Contact	8585342983		saceves@ucsd.edu

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rady Children's Hospital San Diego	Recruiting	San Diego	California	92123	United States

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

De-identified information and samples might be shared with other researchers at other institutions

Types

Not provided

Time Frame

Ongoing

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D057765	Eosinophilic Esophagitis

Ancestor Terms

ID	Term
D004941	Esophagitis
D004935	Esophageal Diseases
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided