7801 sub-study: Role of the Intestinal Microbiome in Eosinophilic Esophagitis (EoE), Eosinophilic Gastritis (EG), and Eosinophilic Colitis (EC)

Status: Closed

The purpose of this study is to identify the amounts and types of bacteria in subjects with Eosinophilic Esophagitis (EoE), Eosinophilic Gastritis (EG), and Eosinophilic Colitis (EC) and compare them with normal controls (healthy individuals).

For Diseases

  • Eosinophilic Esophagitis (EoE)
  • Eosinophilic Gastritis (EG)
  • Eosinophilic Colitis (EC)
  • Healthy individuals

Background

Past studies show that there are differences in the bacteria found in the esophagus of people who have EoE compared to those who do not have EoE. The purpose of this study is to identify the bacteria present in stool, tissue and antibodies in blood from subjects with Eosinophilic Gastrointestinal Diseases (EGIDs): EoE, EG, and EC and compare these bacteria with bacteria found in healthy individuals.

The research questions are:

  1. What bacterial communities are present in the gastrointestinal tract of subjects with EoE, EG, or EC compared to healthy individuals?
  2. What is the bacterial composition in tissue compared to stool?
  3. How does EGIDs treatment and inflammation affect the bacterial community?
  4. Could identification of the bacteria present in stool or antibodies in the serum from patients with EGIDs lead to the development of noninvasive tools to diagnose and predict how the disease will progress?

This is a 2-year longitudinal pilot study of 108 individuals (18 with EoE, 18 with EG, 18 with EC, and 54 healthy individuals to serve as controls for the esophageal, gastric, or colon group.). The population for enrollment includes males and females, ages 3 years or older with presence of symptoms associated with EGIDs (abdominal pain, vomiting, heartburn, feeding/eating problems, swallowing difficulties, food impaction (food blockade), bloody/non-bloody diarrhea), and healthy controls. Biopsies and serum will be collected at a standard of care endoscopy visit and the stool sample can be collected in clinic or at home within a week of the procedure.

Targeted Enrollment

To be eligible to participate, you must:

  • Be male or female and 3 years of age or older
  • Be undergoing standard of care (SOC) endoscopy for clinical indications, including colonoscopies
  • Have mucosal eosinophilia
  • Have EoE - ≥15 eosinophils/HPF OR
  • Have EG - ≥30 eosinophils/HPF OR
  • Have EC - ≥ 65 eosinophils/HPF OR
  • Be a healthy individual without an EGID

You are not eligible to participate if:

  • You have Ehlers-Danlos, Marfan, or Loeys-Dietz syndrome, or bleeding diatheses, or are immunosuppressed
  • You have had antibiotic exposure within past month
  • You have recently enrolled in blinded investigational studies
  • You have Esophageal stricture < 3mm
  • You have other identifiable causes for eosinophilia, infections, GI cancer, other GI inflammatory disease
  • For healthy individuals, you have Inflammatory Bowel Disease, Celiac, or Gastroesophageal Reflux Disease

In order to participate in a study, you must personally contact the study coordinator of any of the participating institutions by phone or by e-mail. Please use the information below to ask about participation.

California

University of California & Rady Children's Hospital, San Diego
Contact: Lea Jacinto, Clinical Research Coordinator
Phone: 858-246-2144
Email: ljacinto@ucsd.edu

Contact: Emad Khosh-hemmat, Clinical Research Coordinator
Phone: 858-966-1700 ext: 226884
Email: ekhoshhe@ucsd.edu

Colorado

Children's Hospital Colorado
Contact: Kendra Kocher, Research Project Manager
Phone: 720-777-5304
Email: kendra.kocher@childrenscolorado.org

University of Colorado
Contact: Allison Dubner, Research Project Manager
Phone: 303-724-8974
Email: allison.dubner@ucdenver.edu

Illinois

Ann & Robert H. Lurie Children's Hospital of Chicago
Contact: Jessica Ross
Phone: 312-227-4582
Email: jnross@luriechildrens.org

Northwestern University
Contact: Angelika Zalewski
Phone: 312-695-4036
Email: angelika.zalewski@northwestern.edu

Massachusetts

Tufts Medical Center
Contact: Pedro Eman, Clinical Research Coordinator
Phone: 617-636-4941
Email: peman@tuftsmedicalcenter.org

North Carolina

University of North Carolina School of Medicine
Contact: Sarah McGee, Clinical Research Coordinator
Phone: 919-966-4591
Email: smcgee@med.unc.edu

Ohio

Cincinnati Children's Hospital Medical Center (CCHMC), Cincinnati
Contact: Heidi Poppendeck, Clinical Research Coordinator
Phone: 513-803-3078
Email: heidi.poppendeck@cchmc.org

Pennsylvania

Children’s Hospital of Philadelphia
Contact: Deirdre Burke
Phone: 267-426-8603
Email: Burked2@email.chop.edu

University of Pennsylvania, Philadelphia
Contact: Maureen DeMarshall
Phone: 215-349-8546
Email: demarshm@mail.med.upenn.edu



Please Note: The Rare Diseases Clinical Research Network will make every effort to enroll all the patients we can, but we cannot make any guarantees that we will be able to enroll everyone in a particular study who wants to participate.