a4b7 Integrin in Eosinophilic Esophagitis

NCT02546219 | Completed

• 1 other identifier: 2015P000816
• Study Type: observational
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Eosinophilic Esophagitis

Keywords

eosinophilic esophagitis; EoE; integrins

Outcome Measures

Primary Outcomes (1)

• 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.

  8 weeks

Study Arms (1)

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.

Interventions

Eosinophil isolation and characterization. OTHER

Peripheral blood and esophageal biopsies will be obtained from study subjects for further analysis of eosinophils integrin profiles.

Adults with EoE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with active eosinophilic esophagitis

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral blood and esophageal eosinophils will be analyzed and may be stored for future studies.

MeSH Terms

Conditions

Eosinophilic Esophagitis

Condition Hierarchy (Ancestors)

Esophagitis; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Gastroenteritis; Eosinophilia; Leukocyte Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• John J Garber, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant in Medicine

Study Record Dates

• First Submitted: September 8, 2015
• First Posted: September 10, 2015
• Study Start: March 1, 2016
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: February 21, 2019

Record last verified: 2019-02

Locations

US (1)