SOFEED: Six Food vs. One Food Eosinophilic Esophagitis Diet Study
SOFEED
Six Food vs One Food Eosinophilic Esophagitis Elimination Diet (SOFEED) Followed by Swallowed Glucocorticoid Trial
2 other identifiers
interventional
129
1 country
9
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started May 2016
Typical duration for phase_2
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 12, 2015
CompletedFirst Posted
Study publicly available on registry
May 20, 2016
CompletedStudy Start
First participant enrolled
May 20, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 17, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 29, 2019
CompletedResults Posted
Study results publicly available
May 26, 2020
CompletedMay 26, 2020
May 1, 2020
2.9 years
October 12, 2015
April 14, 2020
May 18, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Percent of Participants in Histologic Remission (<15 Eos/Hpf)
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)
6 weeks after starting treatment
Secondary Outcomes (6)
Percent of Participants in Complete and Partial Histologic Remission
6 weeks after starting treatment
Percent of Participants Following SGC in Histologic Remission in Phase 2
6 weeks after starting treatment
Percent of Participants Following 6FED in Histologic Remission in Phase 2
6 weeks after starting treatment
Change From Baseline in Peak Eosinophil Count
6 weeks after starting treatment
Change From Baseline in Total Histology Scoring System
6 weeks after starting treatment
- +1 more secondary outcomes
Study Arms (4)
1-Food Elimination Diet (1FED)
ACTIVE COMPARATORParticipants eliminate milk from the diet in Phase 1
6-Food Elimination Diet (6FED)
ACTIVE COMPARATORParticipants eliminate milk, egg, wheat, soy, nuts, fish from the diet in Phase 1
1FED Non-Responders (6FED)
OTHERParticipants 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)
OTHERParticipants that fail to respond to 6FED in Phase 1 administer swallowed glucocorticoids (SGC) (Flovent HFA) 880 mcg twice daily in Phase 2
Interventions
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Children's Hospital Medical Center, Cincinnatilead
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)collaborator
- National Institute of Allergy and Infectious Diseases (NIAID)collaborator
- Office of Rare Diseases (ORD)collaborator
- National Center for Advancing Translational Sciences (NCATS)collaborator
Study Sites (9)
University of California, San Diego
La Jolla, California, 92093, United States
Northwestern University
Chicago, Illinois, 60208, United States
Tufts University
Boston, Massachusetts, 02111, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
University of North Carolina, Chapel Hill
Chapel Hill, North Carolina, 27599, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
University of Utah
Salt Lake City, Utah, 84132, United States
Related Publications (1)
Kliewer KL, Gonsalves N, Dellon ES, Katzka DA, Abonia JP, Aceves SS, Arva NC, Besse JA, Bonis PA, Caldwell JM, Capocelli KE, Chehade M, Cianferoni A, Collins MH, Falk GW, Gupta SK, Hirano I, Krischer JP, Leung J, Martin LJ, Menard-Katcher P, Mukkada VA, Peterson KA, Shoda T, Rudman Spergel AK, Spergel JM, Yang GY, Zhang X, Furuta GT, Rothenberg ME. One-food versus six-food elimination diet therapy for the treatment of eosinophilic oesophagitis: a multicentre, randomised, open-label trial. Lancet Gastroenterol Hepatol. 2023 May;8(5):408-421. doi: 10.1016/S2468-1253(23)00012-2. Epub 2023 Feb 28.
PMID: 36863390DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Marc E. Rothenberg, MD, PhD
- Organization
- Cincinnati Children's Hospital Medical Center
Study Officials
- PRINCIPAL INVESTIGATOR
Marc E Rothenberg, MD, PhD
Children's Hospital Medical Center, Cincinnati
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 12, 2015
First Posted
May 20, 2016
Study Start
May 20, 2016
Primary Completion
April 17, 2019
Study Completion
May 29, 2019
Last Updated
May 26, 2020
Results First Posted
May 26, 2020
Record last verified: 2020-05