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

NCT ID: NCT02610816

Last Updated: 2018-08-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 67 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-21
• Study Completion Date: 2018-05-16

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 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.

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 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.

Conditions

Eosinophilic Esophagitis; Eosinophilic Gastrointestinal Disorders (EGIDs)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1FED

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

Group Type: ACTIVE_COMPARATOR

1 Food Elimination Diet

Intervention Type: OTHER

Participants eliminate milk from the diet for 12 weeks

4FED

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

Group Type: ACTIVE_COMPARATOR

4 Food Elimination Diet

Intervention Type: OTHER

Participants eliminate milk, egg, wheat, soy from the diet for 12 weeks

1FED Non-Responders (4FED)

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

Group Type: OTHER

4 Food Elimination Diet (post 1FED failure)

Intervention Type: OTHER

Participants that fail to respond to 1FED in phase 1 eliminate milk, egg, wheat, soy from the diet for 12 weeks in Phase 2

4FED Non-Responders (SGC)

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

Group Type: OTHER

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

Intervention Type: DRUG

Participants that fail to respond to 4FED in phase 1 administer swallowed glucocorticosteroids (Flovent HFA) 800 mcg twice daily for 12 weeks in Phase 2

Interventions

1 Food Elimination Diet

Participants eliminate milk from the diet for 12 weeks

Intervention Type: OTHER

4 Food Elimination Diet

Participants eliminate milk, egg, wheat, soy from the diet for 12 weeks

Intervention Type: OTHER

4 Food Elimination Diet (post 1FED failure)

Participants that fail to respond to 1FED in phase 1 eliminate milk, egg, wheat, soy from the diet for 12 weeks in Phase 2

Intervention Type: OTHER

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

Participants that fail to respond to 4FED in phase 1 administer swallowed glucocorticosteroids (Flovent HFA) 800 mcg twice daily for 12 weeks in Phase 2

Intervention Type: DRUG

Other Intervention Names

1FED; 4FED

Eligibility Criteria

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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Patient-Centered Outcomes Research Institute

OTHER

Sponsor Role: collaborator

Children's Hospital Medical Center, Cincinnati

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marc E Rothenberg, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital Medical Center, Cincinnati

Locations

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2015-2187

Identifier Type: -

Identifier Source: org_study_id