Phase
Condition
Esophageal Disorders
Ulcers
Gastrointestinal Diseases And Disorders
Treatment
N/AClinical Study ID
Ages 18-60 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Have diagnosis of EoE (based on consensus criteria)
Have histologically confirmed active disease >15 eosinophils/hpf in either distal orproximal esophagus within 12 weeks of screening visit
Symptomatic (have experienced symptoms within the last month prior to enrollment)
Proton pump inhibitor (PPI) confirmation
Have a negative urine pregnancy test at screening if of childbearing potential
Exclusion
Exclusion Criteria:
Have been treated with topical swallowed steroids within the last 2 months or systemicsteroids within the last 3 months
Have pathological eosinophilia in segments of the GI tract other than the esophagusdetermined by local review
Have been diagnosed with a GI malabsorption disorder (i.e., Inflammatory boweldisease, Crohn's disease) or Celiac disease
Are currently on dietary therapy strictly avoiding milk or on a 6FED
Have concurrent H pylori gastritis or parasitic infection
Have history of anaphylaxis to milk (with current avoidance of milk)
Have previously failed strict dietary therapy clearly documented with one of theseregimens or topical steroid treatment (i.e. have achieved histological remission of <15 eos/hpf after having been on fluticasone or >1mg budesonide per day).
Use of investigational drugs within 4 weeks (one month) prior to enrollment
Are concurrently receiving any of the prohibited medications for the study
On immunotherapy for pollen (if not on maintenance therapy) or immunoglobulin-E (IgE) -mediated food allergy
Past or current medical problems or findings from physical examination or laboratorytesting that are not listed above, which, in the opinion of the investigator, may poseadditional risks from participation in the study, may interfere with the participant'sability to comply with study requirements or that may impact the quality orinterpretation of the data obtained from the study.
Study Design
Study Description
Connect with a study center
University of California, San Diego
La Jolla, California 92093
United StatesSite Not Available
Northwestern University
Chicago, Illinois 60208
United StatesSite Not Available
Tufts University
Boston, Massachusetts 02111
United StatesSite Not Available
Mayo Clinic
Rochester, Minnesota 55905
United StatesSite Not Available
Icahn School of Medicine at Mount Sinai
New York, New York 10029
United StatesSite Not Available
University of North Carolina, Chapel Hill
Chapel Hill, North Carolina 27599
United StatesSite Not Available
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio 45229
United StatesSite Not Available
University of Pennsylvania
Philadelphia, Pennsylvania 19104
United StatesSite Not Available
University of Utah
Salt Lake City, Utah 84132
United StatesSite Not Available
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