Eosinophilic Esophagitis Intervention Trial-1 Food vs. 4 Food Elimination Diet Followed by Swallowed Glucocorticoids

Cincinnati Children's Hospital Medical Center

Status and phase: Completed; Phase 3; Phase 2

Conditions: Eosinophilic Gastrointestinal Disorders (EGIDs); Eosinophilic Esophagitis

Treatments: Other: 4 Food Elimination Diet (post 1FED failure); Other: 1 Food Elimination Diet; Drug: Fluticasone Propionate, 800 mcg twice daily (post 4FED failure); Other: 4 Food Elimination Diet

Study type: Interventional

Funder types: Other

Identifiers

NCT02610816

2015-2187

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 4-food elimination diet (4FED, milk, egg, wheat, and soy) for eosinophilic esophagitis (EoE). 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 4FED. Participants will remain on the assigned dietary therapy for 12 weeks. At the end of 12 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 4FED therapy for 12 weeks, and participants who were on 4FED during Phase 1 will receive swallowed glucocorticoid therapy for 12 weeks. At the end of 12 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: 67 patients

Sex: All

Ages: 6 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have diagnosis of EoE (based on consensus criteria)
• Are aged 6 to 17 years
• Have histologically confirmed active disease >15 eosinophils/hpf in either distal or proximal esophagus within 12 weeks of screening visit
• Proton Pump Inhibitor (PPI) confirmation
• Symptomatic (have experienced symptoms within the last month prior to enrollment)
• Has a negative urine pregnancy test at screening if of childbearing potential. Females of childbearing potential must have a negative urine pregnancy test (β-hCG) prior to enrollment into the study (i.e., at screening). Subsequently, these participants must agree to use adequate birth control measures (e.g., condom, oral/injectable/subcutaneous contraceptives, intrauterine device, or sexual abstinence) during the study and for at least one month after the last dose of study drug which will be documented in the source documents.

Exclusion criteria

• Have been treated with topical swallowed steroids within the last 2 months or systemic steroids within the past 3 months
• Have eosinophilia in segments of the GI tract other than the esophagus
• Have been diagnosed with a GI malabsorption disorder (i.e., Inflammatory bowel disease, Crohn's disease) or Celiac disease
• Are currently on dietary therapy avoiding milk
• Have concurrent H pylori gastritis or parasitic infection
• Are unable to obtain esophagogastroduodenoscopy with esophageal biopsies at Cincinnati Children's Hospital Medical Center (CCHMC) or other participating institution within 4 weeks of study completion
• Have previously failed (in a clinical trial setting) dietary therapy with one of these regimens or topical steroid treatment with fluticasone at a total dose of 1760 mcg per day.
• Have definitely responded (in a clinical trial setting) to either dietary therapy avoiding these antigens or to swallowed fluticasone at a total dose of 1760 mcg per day
• Are concurrently receiving any of the prohibited medications listed in Table 2
• On immunotherapy for pollen (if not on maintenance therapy) or immunoglobulin E (IgE)-mediated food allergy.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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67 participants in 4 patient groups

1FED

Active Comparator group

Description:

1-food elimination diet: Participants eliminate milk from the diet in Phase 1

Treatment:

Other: 1 Food Elimination Diet

4FED

Active Comparator group

Description:

4-food elimination diet: Participants eliminate milk, egg, wheat, soy from the diet in Phase 1

Treatment:

Other: 4 Food Elimination Diet

1FED Non-Responders (4FED)

Other group

Description:

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

Treatment:

Other: 4 Food Elimination Diet (post 1FED failure)

4FED Non-Responders (SGC)

Other group

Description:

Participants that fail to respond to 4FED in Phase 1 administer swallowed glucocorticosteroids (Flovent HFA) 800 mcg twice daily in Phase 2

Treatment:

Drug: Fluticasone Propionate, 800 mcg twice daily (post 4FED failure)