COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

a4b7 Integrin in Eosinophilic Esophagitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02546219
Recruitment Status : Completed
First Posted : September 10, 2015
Last Update Posted : February 21, 2019
Information provided by (Responsible Party):
John J. Garber III, MD, Massachusetts General Hospital

Brief 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. 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.

Condition or disease Intervention/treatment
Eosinophilic Esophagitis Other: Eosinophil isolation and characterization.

Layout table for study information
Study Type : Observational
Actual Enrollment : 16 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Investigating the Role of a4b7 Integrin as a Therapeutic Target in Eosinophilic Esophagitis
Actual Study Start Date : March 2016
Actual Primary Completion Date : December 31, 2018
Actual Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
Adults with EoE
Adult patients with active eosinophilic esophagitis will under blood collection and esophagus biopsies in order to perform eosinophil isolation and characterization.
Other: Eosinophil isolation and characterization.
Peripheral blood and esophageal biopsies will be obtained from study subjects for further analysis of eosinophils integrin profiles.

Primary Outcome Measures :
  1. 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.

Biospecimen Retention:   Samples With DNA
Peripheral blood and esophageal eosinophils will be analyzed and may be stored for future studies.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult patients with active eosinophilic esophagitis

Inclusion Criteria:

  1. Able to give written informed consent
  2. Male or female patients aged 18-65 years at time of screening
  3. 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
  4. 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.
  5. 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.
  6. Willing and able to comply with all clinic visits and study-related procedures
  7. Able to understand and complete study-related questionnaires

Exclusion Criteria:

  1. Another disorder that causes esophageal eosinophilia (e.g., hypereosinophilic syndrome, Churg-Strauss, parasitic infection)
  2. 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)
  3. History of the following GI surgeries: fundoplication, gastric surgery or surgery for esophageal atresia
  4. 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.
  5. A stricture on endoscopy that prevents passage of the endoscope
  6. Participation in any investigational drug or device study within 30 days prior to study entry.
  7. Female subjects who are pregnant or nursing.
  8. Chronic infections such as HIV, hepatitis B or C, active mycobacterial (TB) or fungal infections.
  9. Neoplasm or a history of malignancy in the preceding 5 years.
  10. Concurrent infection or disease that may preclude assessment of eosinophilic esophagitis.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02546219

Layout table for location information
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Layout table for investigator information
Principal Investigator: John J Garber, MD Massachusetts General Hospital
Layout table for additonal information
Responsible Party: John J. Garber III, MD, Assistant in Medicine, Massachusetts General Hospital Identifier: NCT02546219    
Other Study ID Numbers: 2015P000816
First Posted: September 10, 2015    Key Record Dates
Last Update Posted: February 21, 2019
Last Verified: February 2019
Keywords provided by John J. Garber III, MD, Massachusetts General Hospital:
eosinophilic esophagitis
Additional relevant MeSH terms:
Layout table for MeSH terms
Eosinophilic Esophagitis
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Leukocyte Disorders
Hematologic Diseases
Hypersensitivity, Immediate
Immune System Diseases