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a4b7 Integrin in Eosinophilic Esophagitis

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2017 by John J. Garber III, MD, Massachusetts General Hospital
Sponsor:
Information provided by (Responsible Party):
John J. Garber III, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT02546219
First received: September 8, 2015
Last updated: March 21, 2017
Last verified: March 2017
  Purpose
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 Intervention
Eosinophilic Esophagitis
Other: Eosinophil isolation and characterization.

Study Type: Observational
Study Design: Observational Model: Other
Time Perspective: Prospective
Official Title: Investigating the Role of a4b7 Integrin as a Therapeutic Target in Eosinophilic Esophagitis

Resource links provided by NLM:


Further study details as provided by John J. Garber III, MD, Massachusetts General Hospital:

Primary Outcome Measures:
  • 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.

Estimated Enrollment: 16
Study Start Date: March 2016
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: November 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

  Eligibility

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

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02546219

Contacts
Contact: John J Garber, MD 617-726-6420 jjgarber@mgh.harvard.edu
Contact: Alexandra C Farris 617-643-2950 acfarris@mgh.harvard.edu

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Alexandra Farris, BS    617-643-2950    acfarris@mgh.harvard.edu   
Principal Investigator: John J Garber, MD         
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: John J Garber, MD Massachusetts General Hospital
  More Information

Responsible Party: John J. Garber III, MD, Assistant in Medicine, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT02546219     History of Changes
Other Study ID Numbers: 2015P000816
Study First Received: September 8, 2015
Last Updated: March 21, 2017

Keywords provided by John J. Garber III, MD, Massachusetts General Hospital:
eosinophilic esophagitis
EoE
integrins

Additional relevant MeSH terms:
Esophagitis
Eosinophilic Esophagitis
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Eosinophilia
Leukocyte Disorders
Hematologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on May 25, 2017