SOFEED: Six Food vs. One Food Eosinophilic Esophagitis Diet Study
NCT ID: NCT02778867
Last Updated: 2020-05-26
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2/PHASE3
129 participants
INTERVENTIONAL
2016-05-20
2019-05-29
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Efficacy and Safety of QAX576 in Patients With Eosinophilic Esophagitis
NCT01022970
Swallowing Characteristics of Pediatric Patients With Eosinophilic Esophagitis
NCT04704752
EDN and Eosinophilic Esophagitis
NCT06387030
Comparison of Esomeprazole to Aerosolized, Swallowed Fluticasone for Eosinophilic Esophagitis
NCT00123656
CEGIR 7808: Use of Unsedated Transnasal Esophagoscopy (TNE) to Monitor Dietary Management of Eosinophilic Esophagitis in Children
NCT03342391
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1-Food Elimination Diet (1FED)
Participants eliminate milk from the diet in Phase 1
1 Food Elimination Diet Therapy
6-Food Elimination Diet (6FED)
Participants eliminate milk, egg, wheat, soy, nuts, fish from the diet in Phase 1
6 Food Elimination Diet Therapy
1FED Non-Responders (6FED)
Participants that fail to respond to 1FED in Phase 1 eliminate milk, egg, wheat, soy, nuts, fish from the diet in Phase 2
6 Food Elimination Diet (after 1FED failure)
6FED Non-responders (SGC)
Participants that fail to respond to 6FED in Phase 1 administer swallowed glucocorticoids (SGC) (Flovent HFA) 880 mcg twice daily in Phase 2
Fluticasone Propionate, 880 mcg twice daily (after 6FED failure)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
1 Food Elimination Diet Therapy
6 Food Elimination Diet Therapy
6 Food Elimination Diet (after 1FED failure)
Fluticasone Propionate, 880 mcg twice daily (after 6FED failure)
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion 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 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.
18 Years
60 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Office of Rare Diseases (ORD)
NIH
National Center for Advancing Translational Sciences (NCATS)
NIH
Children's Hospital Medical Center, Cincinnati
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Marc E Rothenberg, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital Medical Center, Cincinnati
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Informed Consent Form
Document Type: Statistical Analysis Plan
Document Type: Study Protocol
Related Links
Access external resources that provide additional context or updates about the study.
Consortium of Eosinophilic Gastrointestinal Disease Researchers
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2015-1949
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.