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



Status:Recruiting
Conditions:Gastrointestinal, Digestive Disease
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - 60
Updated:1/31/2018
Start Date:November 2015
End Date:July 2020
Contact:Hilary Wilson-Perez, PhD
Email:Hilary.Perez@cchmc.org
Phone:513-803-5074

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Six Food vs One Food Eosinophilic Esophagitis Elimination Diet (SOFEED) Followed by Swallowed Glucocorticoid Trial

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.

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 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 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.

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 4 weeks of screening visit

- Symptomatic (have experienced symptoms within the last month prior to enrollment)

- 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 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.
We found this trial at
6
sites
9500 Gilman Dr
La Jolla, California 92093
(858) 534-2230
Principal Investigator: Seema Aceves, M.D., PhD
Phone: 858-576-1700
The University of California, San Diego UC San Diego is an academic powerhouse and economic...
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Chapel Hill, North Carolina 27599
(919) 962-2211
Principal Investigator: Evan Dellon, M.D., MPH
Phone: 919-966-4591
University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...
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Chapel Hill, NC
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3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
 1-513-636-4200 
Principal Investigator: Marc E Rothenberg, M.D., PhD
Cincinnati Children's Hospital Medical Center Patients and families from across the region and around the...
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Boston, Massachusetts 02111
Principal Investigator: John Leung, M.D.
Phone: 617-636-4941
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303 East Superior Street
Chicago, Illinois 60611
Principal Investigator: Ikuo Hirano, M.D.
Phone: 312-695-4054
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Chicago, IL
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3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Principal Investigator: Gary Falk, M.D., MS
Phone: 215-349-8546
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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