Clinical trial NCT02778867: SOFEED: Six Food vs. One Food Eosinophilic Esophagitis Diet Study
Official title: Six Food vs One Food Eosinophilic Esophagitis Elimination Diet (SOFEED) Followed by Swallowed Glucocorticoid Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Eosinophilic Gastrointestinal Disorders (EGIDs)
Eosinophilic Esophagitis (EoE)
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: National Institute of Allergy and Infectious Diseases (NIAID)
name: Office of Rare Diseases (ORD)
name: National Center for Advancing Translational Sciences (NCATS)
First posted: 2016-05-20
Enrollment: 129
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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 \<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.

Primary outcomes:
measure: Percent of Participants in Histologic Remission (<15 Eos/Hpf)
timeFrame: 6 weeks after starting treatment
Secondary outcomes:
measure: Percent of Participants in Complete and Partial Histologic Remission
timeFrame: 6 weeks after starting treatment
measure: Percent of Participants Following SGC in Histologic Remission in Phase 2
timeFrame: 6 weeks after starting treatment
measure: Percent of Participants Following 6FED in Histologic Remission in Phase 2
timeFrame: 6 weeks after starting treatment
measure: Change From Baseline in Peak Eosinophil Count
timeFrame: 6 weeks after starting treatment
measure: Change From Baseline in Total Histology Scoring System
timeFrame: 6 weeks after starting treatment
measure: Change From Baseline in Total Endoscopic Reference Score
timeFrame: 6 weeks after starting treatment
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: University of California, San Diego
state: California
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Boston
country: United States
facility: Tufts University
state: Massachusetts
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina, Chapel Hill
state: North Carolina
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: Marc E Rothenberg, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: