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

Phase 2

Completed

Conditions: Eosinophilic Gastrointestinal Disorders (EGIDs)
Eosinophilic Esophagitis (EoE)

Interventions: Other: 1 Food Elimination Diet Therapy
Other: 6 Food Elimination Diet Therapy
Other: 6 Food Elimination Diet (after 1FED failure)
Drug: Fluticasone Propionate, 880 mcg twice daily (after 6FED failure)

Registration Number: NCT02778867

Lead Sponsor: Children's Hospital Medical Center, Cincinnati

Brief 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.

Detailed Description: This study will consist of two phases, plus a screening period. During the screening period, subject eligibility for the study will be determined. During Phase 1, qualified participants will be randomly assigned to one of two elimination diet therapies--the 1FED or the 6FED. Participants will remain on the assigned dietary therapy for 6 weeks. At the end of 6 weeks of therapy, esophageal biopsies from participant's standard of care (i.e. normal, routine care) endoscopy will be evaluated to determine disease status. Participants whose EoE is in remission (i.e. \<15 eos/hpf) will be done with the study.

Participants whose EoE is still active (i.e. ≥15 eos/hpf) will have the option to continue into Phase 2 of the study. During Phase 2, participants who were on 1FED in Phase 1 will receive 6FED therapy for 6 weeks, and participants who were on 6FED during Phase 1 will receive swallowed glucocorticoid (SGC) therapy for 6 weeks. At the end of 6 weeks of therapy, esophageal biopsies from participant's standard of care (i.e. normal, routine care) endoscopy will be evaluated to determine disease status.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 129

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1-Food Elimination Diet (1FED)	1 Food Elimination Diet Therapy	Participants eliminate milk from the diet in Phase 1
6-Food Elimination Diet (6FED)	6 Food Elimination Diet Therapy	Participants eliminate milk, egg, wheat, soy, nuts, fish from the diet in Phase 1
1FED Non-Responders (6FED)	6 Food Elimination Diet (after 1FED failure)	Participants that fail to respond to 1FED in Phase 1 eliminate milk, egg, wheat, soy, nuts, fish from the diet in Phase 2
6FED Non-responders (SGC)	Fluticasone Propionate, 880 mcg twice daily (after 6FED failure)	Participants that fail to respond to 6FED in Phase 1 administer swallowed glucocorticoids (SGC) (Flovent HFA) 880 mcg twice daily in Phase 2

Primary Outcome Measures

Name	Time	Method
Percent of Participants in Histologic Remission (<15 Eos/Hpf)	6 weeks after starting treatment	Percent of participants in histologic remission in 1FED versus 6FED groups. Remission is defined as esophageal peak eosinophil count \< 15 eosinophils per high powered field (eos/hpf)

Secondary Outcome Measures

Name	Time	Method
Percent of Participants in Complete and Partial Histologic Remission	6 weeks after starting treatment	Percent of participants in complete and partial histologic remission in 1FED versus 6FED groups. Complete remission is defined as esophageal peak eosinophil count ≤ 1 eosinophils per high powered field (eos/hpf). Partial remission is defined as esophageal peak eosinophil count of 2 - 14 eos/hpf.
Percent of Participants Following SGC in Histologic Remission in Phase 2	6 weeks after starting treatment	Percent of participants who failed 6FED in Phase 1 in histologic remission after following swallowed glucocorticoids (SGC) in Phase 2. Remission is defined as esophageal peak eosinophil count \< 15 eos/hpf
Percent of Participants Following 6FED in Histologic Remission in Phase 2	6 weeks after starting treatment	Percent of participants who failed 1FED in Phase 1 in histologic remission after following 6FED in Phase 2. Remission is defined as esophageal peak eosinophil count \< 15 eos/hpf
Change From Baseline in Peak Eosinophil Count	6 weeks after starting treatment	Peak eosinophil counts were obtained at baseline and 6 weeks. The maximum (highest) peak eosinophil count among distal, mid, and proximal esophageal biopsies was obtained. Change in peak eosinophil count is defined as peak count at 6 weeks minus peak count at baseline. Changes in peak count are compared between 1FED and 6FED. A reduction (negative change) in peak count indicates improvement.
Change From Baseline in Total Histology Scoring System	6 weeks after starting treatment	The histology scoring system (HSS) measures the severity (grade) and extent (stage) of eight histologic abnormalities in the esophagus including eosinophilic inflammation, eosinophilic abscess, eosinophilic surface layering, surface epithelial alteration, dilated intercellular spaces, basal zone hyperplasia, dyskeratotic epithelial cells, and lamina propria fibrosis. Total score is the sum of grade and stage scores from the esophageal biopsy (distal, mid, or proximal) with the highest score (worst abnormalities) divided by the maximum possible score for the biopsy. Total scores range from 0 - 2 (higher scores indicate more severe and/or extensive abnormalities). Histology scores were obtained at baseline and 6 weeks. Change in total histology scoring system (HSS) is defined as total HSS score at 6 weeks minus total HSS score at baseline. Changes in scores are compared between 1FED and 6FED. A reduction (negative change) in score indicates improvement.
Change From Baseline in Total Endoscopic Reference Score	6 weeks after starting treatment	The endoscopic reference score (EREFS) utilizes standardized criteria for the presence and degree of 5 major endoscopic features (edema, fixed rings, exudates, furrows, strictures). Total score is the sum of the five feature scores from the distal and proximal esophagus. Total scores range from 0 - 18 (higher scores indicate worsening features). Endoscopic features were assessed at baseline and 6 weeks. Change in total endoscopic reference score is defined as total score at 6 weeks minus total score at baseline. Changes in scores are compared between 1FED and 6FED. A reduction (negative change) in score indicates improvement.

Trial Locations

Locations (9): Tufts University
🇺🇸
Boston, Massachusetts, United States
Cincinnati Children's Hospital Medical Center
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Cincinnati, Ohio, United States
University of California, San Diego
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La Jolla, California, United States
Northwestern University
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Chicago, Illinois, United States
University of North Carolina, Chapel Hill
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Chapel Hill, North Carolina, United States
Icahn School of Medicine at Mount Sinai
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New York, New York, United States
Mayo Clinic
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Rochester, Minnesota, United States
University of Pennsylvania
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Philadelphia, Pennsylvania, United States
University of Utah
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Salt Lake City, Utah, United States