Eosinophilic EsophagitisEoENCT03980886
Characteristics and Inflammatory Markers in Children With Eosinophilic Esophagitis (EoE)
An observational study of Eosinophilic Esophagitis, run by University of California, San Diego at 1 site in United States.
Trial summary
Single center observational and specimen banking study for children with eosinophilic esophagitis EoE to gauge natural history and inflammatory markers Read more about this study
- Who is it for?
- Ages 1 year to 65 years
- Conditions the study is for
- Eosinophilic Esophagitis
- How many people
- 1,500 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Feb 2019to 17 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The majority of patients who are diagnosed with EoE or suspected EoE at RCHSD/UCSD
Who may be able to join
- 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
Who cannot join
- None
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Rady Children's Hospital San Diego
San Diego, California, 92123
Angie Rodriguez Verdin, BS, 8589661700 ext. 225005, anrodriguezverdin@health.ucsd.edu
Seema Aceves, MD,PhD, 8589665961, saceves@ucsd.edu
About this study
Single center observational and specimen banking study for children with eosinophilic esophagitis EoE to gauge natural history and inflammatory markers
Read the 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.
- Conditions
- Eosinophilic Esophagitis
- Medical subject headings
- Eosinophilic Esophagitis
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2019
- Study start11 Feb 2019
- Primary completion17 Dec 2028 (estimated)
- Study completion17 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eosinophilic EsophagitisStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID)
- Responsible party
- Principal investigator, Seema Aceves, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03980886
- Sponsor's protocol ID
- 181690
- Other IDs
- 2R01DK114457
- Acronym
- EoE
- Status last verified
- Jun 2026
- First submitted
- 23 Apr 2019
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified information and samples might be shared with other researchers at other institutions
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characteristics and Inflammatory Markers in Children With Eosinophilic Esophagitis (EoE)
- ClinicalTrials.gov ID
- NCT03980886
- Acronym / sponsor ID
- EoE / 181690
- Conditions
- Eosinophilic Esophagitis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- 11 Feb 2019 (actual)
- Primary completion
- 17 Dec 2028 (estimated)
- Study completion
- 17 Dec 2028 (estimated)
- First posted
- 10 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 year to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The majority of patients who are diagnosed with EoE or suspected EoE at RCHSD/UCSD
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The longitudinal trajectory of symptoms, endoscopy, and histology in pediatric EoE during routine clinical care
Time frame: 10 years
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
The longitudinal trajectory of inflammatory markers in blood and biopsies in pediatric EoE during routine clinical care
Time frame: 10 years
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Individual participant dataSharing planned: Yes. De-identified information and samples might be shared with other researchers at other institutions
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Eosinophilic Esophagitis, run by University of California, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Angie Rodriguez Verdin, BS (8589661700 ext. 225005, anrodriguezverdin@health.ucsd.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The longitudinal trajectory of symptoms, endoscopy, and histology in pediatric EoE during routine clinical care (time frame: 10 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.