Eosinophilic EsophagitisNCT01988285
Risk Factors and Biomarkers for Diagnosis and Treatment of EoE
An observational study of Eosinophilic Esophagitis, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
Purpose: To validate our previously developed model of risk factors for diagnosis of eosinophilic esophagitis (EoE), and to assess the utility of serum levels of biomarkers in diagnosis and monitoring of treatment of EoE. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Eosinophilic Esophagitis
- What is being tested?
- Specimen Collection and Questionnaires
- How many people
- 800 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jul 2011to 17 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The source of the study population will be patients aged 18 or older presenting at the gastrointestinal (Gl) Endoscopy Clinic at UNC-Chapel Hill for elective upper endoscopy with dysphagia and/or reflux symptoms.
Who may be able to join
- Referral for upper endoscopy (esophagogastroduodenoscopy; EGD) to evaluate specific symptoms (dysphagia, heartburn, reflux, chest pain, regurgitation, abdominal pain, nausea, or vomiting).
- Age 18 or older
Who cannot join
- Acute GI bleeding.
- Known cancer of the esophagus, stomach, or small bowel.
- Prior esophageal resection.
- Esophageal varices.
- Active anticoagulation or bleeding diathesis.
- Medical instability (determined by the performing endoscopist) to precludes performing EGD.
- Pregnancy
- Inability to read or understand the consent form and questionnaire.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina, Chapel Hill
Chapel Hill, North Carolina, 27599
About this study
Purpose: To validate our previously developed model of risk factors for diagnosis of eosinophilic esophagitis (EoE), and to assess the utility of serum levels of biomarkers in diagnosis and monitoring of treatment of EoE. Participants: Up to a total of 800 participants (approximately 400 with EoE and 400 without EoE) who are referred for upper endoscopy. Procedures: This is a prospective cohort study. Patients will be compared with newly diagnosed EoE to non-EoE controls, obtain baseline measures, reassess EoE patients after treatment, and also reassess untreated controls. Data collection will include questionnaire results, blood collection, and tissue collection (esophageal biopsies performed during upper endoscopy per pre-specified protocol). Blood will be analyzed for the presence of the candidate biomarkers. Patients will be compared with newly diagnosed EoE to non-EoE controls, obtain baseline measures, reassess EoE patients after treatment, and also reassess untreated controls. Data collection will include questionnaire results, blood collection, possible saliva collection, possible urine collection, and tissue collection (esophageal biopsies performed during upper endoscopy per pre-specified protocol). Blood will be analyzed for the presence of the candidate biomarkers, including eotaxin-3 and IL-13.
- Conditions
- Eosinophilic Esophagitis
- Being tested
- Specimen Collection, Questionnaires
- Keywords
- Esophagitis, Eosinophilic Esophagitis, Esophageal Diseases, Gastrointestinal Diseases, Digestive System Diseases
- Medical subject headings
- Eosinophilic Esophagitis, Esophagitis, Esophageal Diseases, Gastrointestinal Diseases, Digestive System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Specimen CollectionOther
Blood collection, possible saliva collection, possible urine collection, and biopsy collection
QuestionnairesOther
Subjects will complete a questionnaire utilizing validated symptom-specific instruments (Mayo Dysphagia Scale; GERD-HRQL Scale). The questionnaire will also record patient demographics, medical history, and current and past medication use
| Study group | Role | What they receive |
|---|---|---|
| Dysphagia and GERD controls | The cross-sectional arm will consist of patients who are having a clinically indicated endoscopy for reflux and/or dysphagia.
Cross-sectional participants will have specimens collected and complete a questionnaire. Receives: Other: Specimen Collection; Other: Questionnaires | |
| Prospective Longitudinal EoE Cases | The prospective longitudinal group will be subjects who have a positive EoE diagnosis during initial endoscopy. This prospective group will be followed up at their clinically indicated endoscopy after their standard of care clinical therapy of swallowed steroids.
Prospective longitudinal participants will have specimens collected and complete questionnaires s prior to their standard of care clinical therapy of swallowed steroids and at their clinically indicated follow up upper endoscopy. Receives: Other: Specimen Collection; Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Risk factors in EoE diagnosis
To validate our model of clinical, endoscopic, and histopathologic risk factors for diagnosis of EoE by calculating the EoE risk score which includes subject's age, allergic conditions, endoscopic findings, and eosinophil count. Subject's EoE risk scores will be compared between EoE patients and two non-EoE control groups: patients with dysphagia and patients with gastroesophageal reflux disease (GERD) who are not responsive to proton pump inhibitor (PPI) therapy.
Measured: Enrollment (day 1)
Secondary outcomes (1)
Inflammatory serum biomarker measures
To assess operating characteristics of serum biomarkers eotaxin-3 and IL-13 for diagnosis of incident cases of EoE as compared with two non-EoE control groups: patients with dysphagia and patients with GERD who are not responsive to PPI therapy.
Measured: Enrollment (day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2013 (estimated)
- Study start28 Jul 2011
- Primary completion17 Jul 2024
- Study completion17 Jul 2024
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 North Carolina, Chapel HillThe 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
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Evan S Dellon, MD, MPH, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01988285
- Sponsor's protocol ID
- 11-1122
- Other IDs
- K23DK090073
- Status last verified
- Jun 2026
- First submitted
- 25 Oct 2013
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors and Biomarkers for Diagnosis and Treatment of EoE
- ClinicalTrials.gov ID
- NCT01988285
- Acronym / sponsor ID
- 11-1122
- Conditions
- Eosinophilic Esophagitis
- Keywords
- Esophagitis, Eosinophilic Esophagitis, Esophageal Diseases, Gastrointestinal Diseases, Digestive System Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- 28 Jul 2011 (actual)
- Primary completion
- 17 Jul 2024 (actual)
- Study completion
- 17 Jul 2024 (actual)
- First posted
- 20 Nov 2013 (estimated)
- 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.
Purpose: To validate our previously developed model of risk factors for diagnosis of eosinophilic esophagitis (EoE), and to assess the utility of serum levels of biomarkers in diagnosis and monitoring of treatment of EoE. Participants: Up to a total of 800 participants (approximately 400 with EoE and 400 without EoE) who are referred for upper endoscopy. Procedures: This is a prospective cohort study. Patients will be compared with newly diagnosed EoE to non-EoE controls, obtain baseline measures, reassess EoE patients after treatment, and also reassess untreated controls. Data collection will include questionnaire results, blood collection, and tissue collection (esophageal biopsies performed during upper endoscopy per pre-specified protocol). Blood will be analyzed for the presence of the candidate biomarkers. Patients will be compared with newly diagnosed EoE to non-EoE controls, obtain baseline measures, reassess EoE patients after treatment, and also reassess untreated controls. Data collection will include questionnaire results, blood collection, possible saliva collection, possible urine collection, and tissue collection (esophageal biopsies performed during upper endoscopy per pre-specified protocol). Blood will be analyzed for the presence of the candidate biomarkers, including eotaxin-3 and IL-13.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dysphagia and GERD controls | – | Other: Specimen Collection, Other: QuestionnairesThe cross-sectional arm will consist of patients who are having a clinically indicated endoscopy for reflux and/or dysphagia. Cross-sectional participants will have specimens collected and complete a questionnaire. |
| Prospective Longitudinal EoE Cases | – | Other: Specimen Collection, Other: QuestionnairesThe prospective longitudinal group will be subjects who have a positive EoE diagnosis during initial endoscopy. This prospective group will be followed up at their clinically indicated endoscopy after their standard of care clinical therapy of swallowed steroids. Prospective longitudinal participants will have specimens collected and complete questionnaires s prior to their standard of care clinical therapy of swallowed steroids and at their clinically indicated follow up upper endoscopy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The source of the study population will be patients aged 18 or older presenting at the gastrointestinal (Gl) Endoscopy Clinic at UNC-Chapel Hill for elective upper endoscopy with dysphagia and/or reflux symptoms.
Key inclusion criteria (2 listed)
- Referral for upper endoscopy (esophagogastroduodenoscopy; EGD) to evaluate specific symptoms (dysphagia, heartburn, reflux, chest pain, regurgitation, abdominal pain, nausea, or vomiting).
- Age 18 or older
Key exclusion criteria (8 listed)
- Acute GI bleeding.
- Known cancer of the esophagus, stomach, or small bowel.
- Prior esophageal resection.
- Esophageal varices.
- Active anticoagulation or bleeding diathesis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Specimen CollectionBlood collection, possible saliva collection, possible urine collection, and biopsy collection | Other | Dysphagia and GERD controls, Prospective Longitudinal EoE Cases |
| QuestionnairesSubjects will complete a questionnaire utilizing validated symptom-specific instruments (Mayo Dysphagia Scale; GERD-HRQL Scale). The questionnaire will also record patient demographics, medical history, and current and past medication use | Other | Dysphagia and GERD controls, Prospective Longitudinal EoE Cases |
Primary outcome
Risk factors in EoE diagnosis
Time frame: Enrollment (day 1)
To validate our model of clinical, endoscopic, and histopathologic risk factors for diagnosis of EoE by calculating the EoE risk score which includes subject's age, allergic conditions, endoscopic findings, and eosinophil count. Subject's EoE risk scores will be compared between EoE patients and two non-EoE control groups: patients with dysphagia and patients with gastroesophageal reflux disease (GERD) who are not responsive to proton pump inhibitor (PPI) therapy.
1 secondary outcome
Inflammatory serum biomarker measures
Time frame: Enrollment (day 1)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Evan S Dellon, MD, MPH principal investigator
University of North Carolina, Chapel Hill
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 North Carolina, Chapel Hill 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 2 inclusion and 8 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: finished, as of the sponsor's last update on 26 Jun 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Risk factors in EoE diagnosis (time frame: Enrollment (day 1)). 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 26 Jun 2026.