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Outcome Measures in Eosinophilic Gastrointestinal Disorders

September 9, 2019

Overview

The aim of this study is to twofold: firstly, to find the best measures to define how well a person with eosinophilic disorder is doing and additionally, to see if standard questionnaires are helpful and accurate. It will be doing this by looking at tissue components taken from patients who have had an endoscopy and/or colonoscopy, and comparing these samples with the symptoms experienced by the patient. 

 

Study Information

This is a longitudinal observational study in which individuals with eosinophilic esophagitis (EoE), eosinophilic gastritis (EG), and eosinophilic colitis (EC) will be followed over an extended period of time. 

Participants undergoing endoscopies and/or colonoscopies will have biopsies (small pieces of tissue from the GI tract normally collected during these procedures) collected and used for the research study. Participants will also complete questionnaires related to their symptoms and quality of life. They will be followed over the course of time and asked to complete the questionnaires at various time points throughout the study.

There will be an estimated 1050 participants taking part in the study. It began in July 2015 and is estimated to be completed in January 2051.

 

Participants will be randomly allocated 1:1 to receive either NuShield® and SOC, or SOC alone following the 14 day screening period. Following this, subjects will be seen weekly for up to 24 weeks. Subjects that are placed into the SOC group, but whose diabetic foot ulcer has not healed by week 12 may be crossed over to receive NuShield® and followed for an additional 12-14 weeks.

 

Inclusion Criteria

  • Males or females 3 years of age and older
  • Mucosal eosinophilia (≥15 eos/hpf for EoE, ≥30 eos/hpf for EG, ≥32 eos/hpf for EC)
  • Presence of symptoms is required for patients who are newly diagnosed but not required for patients who were previously diagnosed
  • EC patients must have a history of one of the following at the time of colonoscopy:
  1. anemia
  2. peripheral eosinophilia
  3. hemoccult positive stool
  4. EGID
  5. allergic disease (allergic rhinitis, asthma, food allergy, eczema or other allergic features suggestive of atopic disease)

 

Exclusion Criteria

  • History of intestinal surgery other than G tube placement
  • Enrolled in a blinded investigational study
  • Have esophageal stricture (<3mm)
  • Have other identifiable causes for eosinophilia (except Inflammatory Bowel Disease): infections, Gastrointestinal (GI) cancer, other GI inflammatory disease (e.g., Ulcerative Colitis or Crohn’s Disease)

 

Location

This study is taking place in the United States, in the following locations: University of California, San Diego; University of Colorado, Denver; Childrens Hospital Colorado, Denver; Northwestern University, Illinois; Ann and Robert H. Lurie Children’s Hospital of Chicag, Illinois; University of Peoria, Illinois; National Institutes of Health (NIH), Maryland; Tufts University, Massachusetts; Icahn School of Medicine at Mount Sinai, New York; University of North Carolina, North Carolina; Cincinnati Children’s Hospital Medical Center, Ohio; Children’s Hospital of Philadelphia, Pennsylvania; University of Pennsylvania, Pennsylvania; Baylor College of Medicine & Texas Children’s Hospital, Texas; University of Utah, Utah.

For further information, please contact Heidi Poppendeck, MPH on 513-803-3078 or Heidi.poppendeck@cchmc.org, or Kara Kliewer, PhD on 513-636-4821 or kara.kliewer@cchmc.org

 

Sponsors / Collaborators

This study is sponsored by Children’s Hospital Medical Center, Cincinnati; National Institute of Allergy and Infectious Diseases (NIAID); National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); Office of Rare Diseases (ORD), and National Center for Advancing Translational Science (NCATS). The principal investigator is Marc E Rothenberg, MD, PhD of Children’s Hospital Medical Center, Cincinnati.

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