Eosinophilic EsophagitisNCT02546219
a4b7 Integrin in Eosinophilic Esophagitis
An observational study of Eosinophilic Esophagitis, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The overall objective of this preclinical study is to further the investigators mechanistic understanding of the role that the α4β7 and mucosal addressin cell adhesion molecule (MAdCAM-1) pathway plays in mediating eosinophil recruitment in 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?
- Eosinophil isolation and characterization.
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2016to 31 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 with active eosinophilic esophagitis
Who may be able to join
- Able to give written informed consent
- Male or female patients aged 18-65 years at time of screening
- Confirmed active EoE at screening or within 8 weeks prior to baseline visit, as defined by esophageal mucosal eosinophils ≥15 per high power field (HPF, 400X magnification) despite at least 4 weeks of proton pump inhibitor (PPI) therapy with omeprazole 20 mg twice daily or the equivalent. updated 14APR2015 Page 8 of 19
- Within the week prior to dosing, patient has one of the following symptoms of moderate, or worse, severity: dysphagia, vomiting, regurgitation, abdominal pain, chest pain/heartburn.
- Maintained on a stabilized diet for at least 6 weeks prior to screening and during the course of the study; stable diet is defined as no initiation of single or multiple elimination diets or reintroduction of previously eliminated food groups.
- Willing and able to comply with all clinic visits and study-related procedures
- Able to understand and complete study-related questionnaires
Who cannot join
- Another disorder that causes esophageal eosinophilia (e.g., hypereosinophilic syndrome, Churg-Strauss, parasitic infection)
- History of abnormal gastric or duodenal biopsy or documented GI disorders other than EoE (e.g., celiac disease, Crohn's disease or H. pylori infection)
- History of the following GI surgeries: fundoplication, gastric surgery or surgery for esophageal atresia
- Use of systemic immunosuppressive or immunomodulating agents (oral prednisone, anti-immunoglobulin E (IgE) monoclonal antibody (mAb), methotrexate, cyclosporine, INFα, or anti-TNF) within six months prior to study entry.
- A stricture on endoscopy that prevents passage of the endoscope
- Participation in any investigational drug or device study within 30 days prior to study entry.
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- Female subjects who are pregnant or nursing.
- Chronic infections such as HIV, hepatitis B or C, active mycobacterial (TB) or fungal infections.
- Neoplasm or a history of malignancy in the preceding 5 years.
- Concurrent infection or disease that may preclude assessment of eosinophilic esophagitis.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Investigating the Role of a4b7 Integrin as a Therapeutic Target in Eosinophilic Esophagitis
The overall objective of this preclinical study is to further the investigators mechanistic understanding of the role that the α4β7 and mucosal addressin cell adhesion molecule (MAdCAM-1) pathway plays in mediating eosinophil recruitment in EoE. To accomplish this, the investigators aim to (1) determine the baseline and dynamic patterns of α4β7 integrin expression on circulating and tissue eosinophils in EoE and in the setting of non-EoE esophageal eosinophilia (e.g., reflux esophagitis) and (2) determine the complete profile of eosinophil integrin molecules that may play a role in active EoE.
- Conditions
- Eosinophilic Esophagitis
- Being tested
- Eosinophil isolation and characterization.
- Keywords
- eosinophilic esophagitis, EoE, integrins
- Medical subject headings
- Eosinophilic Esophagitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eosinophil isolation and characterization.Other
Peripheral blood and esophageal biopsies will be obtained from study subjects for further analysis of eosinophils integrin profiles.
| Study group | Role | What they receive |
|---|---|---|
| Adults with EoE | Adult patients with active eosinophilic esophagitis will under blood collection and esophagus biopsies in order to perform eosinophil isolation and characterization. Receives: Other: Eosinophil isolation and characterization. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of eosinophils expressing a4b7 integrin
Eosinophil expression levels of a4b7 integrin will be assessed on peripheral and esophageal eosinophils during active EoE and after treatment-induced remission.
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 posted10 Sep 2015 (estimated)
- Study startMar 2016
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
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 Massachusetts General HospitalThe 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
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John J. Garber III, MD, Massachusetts General Hospital
- Investigators
- John J Garber, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02546219
- Sponsor's protocol ID
- 2015P000816
- Status last verified
- Feb 2019
- First submitted
- 8 Sep 2015
- Last updated
- 21 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Role of a4b7 Integrin as a Therapeutic Target in Eosinophilic Esophagitis
- ClinicalTrials.gov ID
- NCT02546219
- Acronym / sponsor ID
- 2015P000816
- Conditions
- Eosinophilic Esophagitis
- Keywords
- eosinophilic esophagitis, EoE, integrins
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Mar 2016 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 10 Sep 2015 (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 overall objective of this preclinical study is to further the investigators mechanistic understanding of the role that the α4β7 and mucosal addressin cell adhesion molecule (MAdCAM-1) pathway plays in mediating eosinophil recruitment in EoE. To accomplish this, the investigators aim to (1) determine the baseline and dynamic patterns of α4β7 integrin expression on circulating and tissue eosinophils in EoE and in the setting of non-EoE esophageal eosinophilia (e.g., reflux esophagitis) and (2) determine the complete profile of eosinophil integrin molecules that may play a role in active EoE.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults with EoE | – | Other: Eosinophil isolation and characterization.Adult patients with active eosinophilic esophagitis will under blood collection and esophagus biopsies in order to perform eosinophil isolation and characterization. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with active eosinophilic esophagitis
Key inclusion criteria (7 listed)
- Able to give written informed consent
- Male or female patients aged 18-65 years at time of screening
- Confirmed active EoE at screening or within 8 weeks prior to baseline visit, as defined by esophageal mucosal eosinophils ≥15 per high power field (HPF, 400X magnification) despite at least 4 weeks of proton pump inhibitor (PPI) therapy with omeprazole 20 mg twice daily or the equivalent. updated 14APR2015 Page 8 of 19
- Within the week prior to dosing, patient has one of the following symptoms of moderate, or worse, severity: dysphagia, vomiting, regurgitation, abdominal pain, chest pain/heartburn.
- Maintained on a stabilized diet for at least 6 weeks prior to screening and during the course of the study; stable diet is defined as no initiation of single or multiple elimination diets or reintroduction of previously eliminated food groups.
Key exclusion criteria (10 listed)
- Another disorder that causes esophageal eosinophilia (e.g., hypereosinophilic syndrome, Churg-Strauss, parasitic infection)
- History of abnormal gastric or duodenal biopsy or documented GI disorders other than EoE (e.g., celiac disease, Crohn's disease or H. pylori infection)
- History of the following GI surgeries: fundoplication, gastric surgery or surgery for esophageal atresia
- Use of systemic immunosuppressive or immunomodulating agents (oral prednisone, anti-immunoglobulin E (IgE) monoclonal antibody (mAb), methotrexate, cyclosporine, INFα, or anti-TNF) within six months prior to study entry.
- A stricture on endoscopy that prevents passage of the endoscope
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 |
|---|---|---|
| Eosinophil isolation and characterization.Peripheral blood and esophageal biopsies will be obtained from study subjects for further analysis of eosinophils integrin profiles. | Other | Adults with EoE |
Primary outcome
Percentage of eosinophils expressing a4b7 integrin
Time frame: 8 weeks
Eosinophil expression levels of a4b7 integrin will be assessed on peripheral and esophageal eosinophils during active EoE and after treatment-induced remission.
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 21 Feb 2019.
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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.
John J Garber, MD principal investigator
Massachusetts General Hospital
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 Massachusetts General Hospital 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 7 inclusion and 10 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 21 Feb 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?
Percentage of eosinophils expressing a4b7 integrin (time frame: 8 weeks). 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 21 Feb 2019.