A Study to Identify Outcome Measures in Eosinophilic Gastrointestinal Disorders

Overview

About this study

The purpose of this observational study is to find the best measures to define how well a person with eosinophilic disorder is doing. People with eosinophilic esophagitis (EoE), eosinophilic gastritis (EG), and eosinophilic colitis (EC) normally undergo endoscopy and/or colonoscopy (scope down the throat or up the bottom) where tissue specimens are collected for microscopic analysis. Treatments are then decided based on how the tissue looks. We are aiming to compare different tissue components such as inflammatory cell types with clinical symptoms. We want to see if scores on standard questionnaires can give us an idea how well the person is doing.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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:
- anemia;
- peripheral eosinophilia;
- hemoccult positive stool;
- Eosinophilic Gastrointestinal Disease (EGID);
- 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).

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location	Status	Contact
Scottsdale/Phoenix, Ariz. Mayo Clinic principal investigator Benjamin Wright, M.D.	Open for enrollment	Contact information: Benjamin Wright M.D. (480) 301-4284 Wright.Benjamin@mayo.edu

Mayo Clinic Location

Status

Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Benjamin Wright, M.D.

Open for enrollment

Contact information:

Benjamin Wright M.D.

(480) 301-4284

Wright.Benjamin@mayo.edu

More information

Publications

Publications are currently not available

Clinical Trials