SOFEED: Six Food vs. One Food Eosinophilic Esophagitis Diet Study

• Status: Completed
• Trial end date: 2019-05-29
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this interventional study is to test and compare the effectiveness of two elimination diets-the 1-food elimination diet (1FED, milk only) and the 6-food elimination diet (6FED, milk, egg, wheat, soy, tree nut/peanuts, and fish/shellfish). The study will also test the effectiveness of swallowed glucocorticoid therapy in some of the study participants for whom diet therapy was not effective.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Children's Hospital Medical Center, Cincinnati
• Collaborators: National Center for Advancing Translational Science (NCATS); National Institute of Allergy and Infectious Diseases (NIAID); National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); Office of Rare Diseases (ORD)
• Treatments: Fluticasone; Glucocorticoids; Xhance

Criteria

Inclusion Criteria:

• Have diagnosis of EoE (based on consensus criteria)

• Have histologically confirmed active disease >15 eosinophils/hpf in either distal or proximal 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 Criteria:

• Have been treated with topical swallowed steroids within the last 2 months or systemic steroids within the last 3 months

• Have pathological eosinophilia in segments of the GI tract other than the esophagus determined by local review

• Have been diagnosed with a GI malabsorption disorder (i.e., Inflammatory bowel disease, 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 these regimens 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 laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study.