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

Cincinnati Children's Hospital Medical Center

Status and phase: Completed; Phase 3; Phase 2

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

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02778867

U54AI117804 (U.S. NIH Grant/Contract)

2015-1949

Details and patient eligibility

About

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.

Full 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.

Enrollment: 129 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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129 participants in 4 patient groups

1-Food Elimination Diet (1FED)

Active Comparator group

Description:

Participants eliminate milk from the diet in Phase 1

Treatment:

Other: 1 Food Elimination Diet Therapy

6-Food Elimination Diet (6FED)

Active Comparator group

Description:

Participants eliminate milk, egg, wheat, soy, nuts, fish from the diet in Phase 1

Treatment:

Other: 6 Food Elimination Diet Therapy

1FED Non-Responders (6FED)

Other group

Description:

Participants that fail to respond to 1FED in Phase 1 eliminate milk, egg, wheat, soy, nuts, fish from the diet in Phase 2

Treatment:

Other: 6 Food Elimination Diet (after 1FED failure)

6FED Non-responders (SGC)

Other group

Description:

Participants that fail to respond to 6FED in Phase 1 administer swallowed glucocorticoids (SGC) (Flovent HFA) 880 mcg twice daily in Phase 2

Treatment:

Drug: Fluticasone Propionate, 880 mcg twice daily (after 6FED failure)