SOFEED: Six Food vs. One Food Eosinophilic Esophagitis Diet Study
Completed · Phase 2/Phase 3
Conditions studied: Eosinophilic Gastrointestinal Disorders (EGIDs), Eosinophilic Esophagitis (EoE)
In brief
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.
Key facts
- Study ID
- NCT02778867
- Run by
- Children's Hospital Medical Center, Cincinnati
- People needed
- 129
- Starts
- 2016-05-20
- Expected to finish
- 2019-05-29
- Last updated by the study team
- 2020-05-26
Who can join
Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- University of California, San Diego — La Jolla, California, United States
- Northwestern University — Chicago, Illinois, United States
- Tufts University — Boston, Massachusetts, United States
- Mayo Clinic — Rochester, Minnesota, United States
- Icahn School of Medicine at Mount Sinai — New York, New York, United States
- University of North Carolina, Chapel Hill — Chapel Hill, North Carolina, United States
- Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
- University of Pennsylvania — Philadelphia, Pennsylvania, United States
- University of Utah — Salt Lake City, Utah, United States
Full record on ClinicalTrials.gov
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