Eosinophilic EsophagitisEoENCT02775045
Eosinophil β1 Integrin Activation as a Biomarker for Eosinophilic Esophagitis
An observational study of Eosinophilic Esophagitis, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
The purpose of this study is to improve the overall management of patients with Eosinophil Esophagitis. Currently, the best way to monitor Eosinophil Esophagitis is repeating the endoscopy procedure. 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?
- Observation Period
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Aug 2016to 13 Dec 2018
- 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: Adult patients (>18 yr) will be recruited from the Gastroenterology clinic following a diagnostic endoscopy for esophageal dysfunction with predominant symptom(s) of solid food dysphagia and/or esophageal food impaction. Patients with esophageal biopsy showing greater than 15 EOS/hpf (pathology results typically available within three business days) despite greater than two months use of high dose proton pump inhibitor will be invited to participate and enroll in the study within 1 week of the endoscopy.
Who may be able to join
- Male or female with no health concerns that might affect the outcome of the study,
- Age 18 years of age and older
- Esophageal dysfunction with a predominant symptom of solid food dysphagia and/or esophageal food impaction
- Esophageal eosinophilia (>15 eosinophils/HPF) shown on biopsy
- In the opinion of the investigator, capable and willing to grant written informed consent and cooperate with study procedures and requirements.
Who cannot join
- Major health problems such as autoimmune disease, heart disease, type I and II diabetes, uncontrolled hypertension or lung diseases other than asthma. The listed health problems are definitive exclusion but decisions regarding major health problems not listed will be based upon the judgment of the investigator,
- Pregnant or lactating females or has a planned pregnancy during the course of the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
UW Madison School of Medicine and Public Health
Madison, Wisconsin, 53792
About this study
The purpose of this study is to improve the overall management of patients with Eosinophil Esophagitis. Currently, the best way to monitor Eosinophil Esophagitis is repeating the endoscopy procedure. The investigators plan to identify a biomarker in the blood (a measurable substance) that tracks with disease activity and will reduce the need for follow-up endoscopies.
Read the detailed description
By definition, Eosinophil Esophagitis involves the presence of eosinophils in the esophageal mucosa. Although incompletely understood, the pathophysiology of Eosinophil Esophagitis is thought to include food allergen driven inflammation in the esophageal mucosa that triggers release of mediators for recruitment of eosinophils. The mediators, such as eotaxin, invoke eosinophil activation and trafficking into the esophageal tissue. The subsequent release of mediators from eosinophils and other cells, including mast cells and basophils, promotes inflammation and fibrosis resulting in Eosinophil Esophagitis symptoms. This protocol focuses on early eosinophil activation events in Eosinophil Esophagitis in the peripheral circulation, specifically activation of surface β1 integrin, as a biomarker for disease activity reflecting eosinophils destined for trafficking into the esophagus. Demonstrating a correlation between disease activity and a peripheral biomarker may ultimately facilitate a timelier, less invasive and less costly management strategy for Eosinophil Esophagitis.
- Conditions
- Eosinophilic Esophagitis
- Being tested
- Observation Period
- Keywords
- EoE
- Medical subject headings
- Eosinophilic Esophagitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observation PeriodOther
8 week observational period
| Study group | Role | What they receive |
|---|---|---|
| Eosinophil esophagitis | Adult patients (>18 yr) will be recruited from the Gastroenterology clinic following a diagnostic endoscopy for esophageal dysfunction with predominant symptom(s) of solid food dysphagia and/or esophageal food impaction. Patients with esophageal biopsy showing greater than 15 eosinophil/hpf (pathology results typically available within three business days) despite greater than two months use of high dose proton pump inhibitor will be invited to participate and enroll in the study within 1 week of the endoscopy. Receives: Other: Observation Period |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eosinophil Esophagitis symptom score
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2016 (estimated)
- Study start30 Aug 2016
- Primary completion13 Dec 2018
- Study completion13 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Eosinophilic EsophagitisStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID)
- Responsible party
- Sponsor
- Investigators
- Sameer Mathur, MD/PhD, Principal investigator, UW Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02775045
- Sponsor's protocol ID
- 2016-0508
- Other IDs
- R21AI122103-01A1
- Acronym
- EoE
- Status last verified
- Jan 2019
- First submitted
- 13 May 2016
- Last updated
- 30 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
Bartig KA, Lee KE, Mosher DF, Mathur SK, Johansson MW. Platelet association with leukocytes in active eosinophilic esophagitis. PLoS One. 2021 Apr 23;16(4):e0250521. doi: 10.1371/journal.pone.0250521. eCollection 2021.
PubMed 33891621
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eosinophil β1 Integrin Activation as a Biomarker for Eosinophilic Esophagitis
- ClinicalTrials.gov ID
- NCT02775045
- Acronym / sponsor ID
- EoE / 2016-0508
- Conditions
- Eosinophilic Esophagitis
- Keywords
- EoE
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- 30 Aug 2016 (actual)
- Primary completion
- 13 Dec 2018 (actual)
- Study completion
- 13 Dec 2018 (actual)
- First posted
- 17 May 2016 (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.
The purpose of this study is to improve the overall management of patients with Eosinophil Esophagitis. Currently, the best way to monitor Eosinophil Esophagitis is repeating the endoscopy procedure. The investigators plan to identify a biomarker in the blood (a measurable substance) that tracks with disease activity and will reduce the need for follow-up endoscopies.
Detailed description
By definition, Eosinophil Esophagitis involves the presence of eosinophils in the esophageal mucosa. Although incompletely understood, the pathophysiology of Eosinophil Esophagitis is thought to include food allergen driven inflammation in the esophageal mucosa that triggers release of mediators for recruitment of eosinophils. The mediators, such as eotaxin, invoke eosinophil activation and trafficking into the esophageal tissue. The subsequent release of mediators from eosinophils and other cells, including mast cells and basophils, promotes inflammation and fibrosis resulting in Eosinophil Esophagitis symptoms. This protocol focuses on early eosinophil activation events in Eosinophil Esophagitis in the peripheral circulation, specifically activation of surface β1 integrin, as a biomarker for disease activity reflecting eosinophils destined for trafficking into the esophagus. Demonstrating a correlation between disease activity and a peripheral biomarker may ultimately facilitate a timelier, less invasive and less costly management strategy for Eosinophil Esophagitis.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Eosinophil esophagitis | – | Other: Observation PeriodAdult patients (>18 yr) will be recruited from the Gastroenterology clinic following a diagnostic endoscopy for esophageal dysfunction with predominant symptom(s) of solid food dysphagia and/or esophageal food impaction. Patients with esophageal biopsy showing greater than 15 eosinophil/hpf (pathology results typically available within three business days) despite greater than two months use of high dose proton pump inhibitor will be invited to participate and enroll in the study within 1 week of the endoscopy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients (>18 yr) will be recruited from the Gastroenterology clinic following a diagnostic endoscopy for esophageal dysfunction with predominant symptom(s) of solid food dysphagia and/or esophageal food impaction. Patients with esophageal biopsy showing greater than 15 EOS/hpf (pathology results typically available within three business days) despite greater than two months use of high dose proton pump inhibitor will be invited to participate and enroll in the study within 1 week of the endoscopy.
Key inclusion criteria (5 listed)
- Male or female with no health concerns that might affect the outcome of the study,
- Age 18 years of age and older
- Esophageal dysfunction with a predominant symptom of solid food dysphagia and/or esophageal food impaction
- Esophageal eosinophilia (>15 eosinophils/HPF) shown on biopsy
- In the opinion of the investigator, capable and willing to grant written informed consent and cooperate with study procedures and requirements.
Key exclusion criteria (2 listed)
- Major health problems such as autoimmune disease, heart disease, type I and II diabetes, uncontrolled hypertension or lung diseases other than asthma. The listed health problems are definitive exclusion but decisions regarding major health problems not listed will be based upon the judgment of the investigator,
- Pregnant or lactating females or has a planned pregnancy during the course of the study.
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 |
|---|---|---|
| Observation Period8 week observational period | Other | Eosinophil esophagitis |
Primary outcome
Eosinophil Esophagitis symptom score
Time frame: 8 weeks
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 30 Jan 2019.
- Derived from this study: PubMed 33891621Bartig KA, Lee KE, Mosher DF, Mathur SK, Johansson MW. Platelet association with leukocytes in active eosinophilic esophagitis. PLoS One. 2021 Apr 23;16(4):e0250521. doi: 10.1371/journal.pone.0250521. eCollection 2021.
- Individual participant dataSharing planned: Yes
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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.
Sameer Mathur, MD/PhD principal investigator
UW Madison
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 Wisconsin, Madison 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 2 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 30 Jan 2019. 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?
Eosinophil Esophagitis symptom score (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02775045, which also lists 1 linked publication.
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 30 Jan 2019.