Phase 3 N=129 Randomized Treatment

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

Eosinophilic Gastrointestinal Disorders (EGIDs) · Eosinophilic Esophagitis (EoE)

Bottom Line

View on ClinicalTrials.gov: NCT02778867 ↗

Enrolled (actual)

129

Serious AEs

0.6%

Results posted

May 2020

Primary outcome: Primary: Percent of Participants in Histologic Remission (<15 Eos/Hpf) — 34.3; 40.3 percentage of participants — p=0.58

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: 1 Food Elimination Diet Therapy (Other); 6 Food Elimination Diet Therapy (Other); 6 Food Elimination Diet (after 1FED failure) (Other); Fluticasone Propionate, 880 mcg twice daily (after 6FED failure) (Drug)
Age: Adult · 18+ yrs
Sex: All
Sponsor: Children's Hospital Medical Center, Cincinnati
Primary completion: Apr 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Percent of Participants in Histologic Remission (<15 Eos/Hpf)	34.3; 40.3	0.58
SECONDARY Percent of Participants in Complete and Partial Histologic Remission	6.0; 21.0; 28.4; 19.4	0.06
SECONDARY Percent of Participants Following SGC in Histologic Remission in Phase 2	81.8	—
SECONDARY Percent of Participants Following 6FED in Histologic Remission in Phase 2	42.9	—
SECONDARY Change From Baseline in Peak Eosinophil Count	-18; -22	0.90
SECONDARY Change From Baseline in Total Histology Scoring System	-0.15; -0.23	0.22
SECONDARY Change From Baseline in Total Endoscopic Reference Score	-1.0; -2.0	0.71

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.

Eligibility 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 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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02778867). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.