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

NCT02610816 | Completed Phase 2 Results DMC

• 1 other identifier: 2015-2187
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

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.

Conditions

Eosinophilic Esophagitis; Eosinophilic Gastrointestinal Disorders (EGIDs)

Outcome Measures

Primary Outcomes (2)

• Change From Baseline in Pediatric EoE Symptom Score Version 2.0 (PEESS V2.0) at 12 Weeks

  The PEESS V2.0 questionnaire captures EoE-specific symptoms (dysphagia, gastro-esophageal reflux disease (GERD), nausea/vomiting, and pain) as reported by children with EoE (8-18 years of age) and their parents (for children 2-18 years of age). The range for PEESS v2.0 scores is 0 to 100, with a higher score being indicative of more frequent and/or severe symptoms. Scores were obtained at baseline and 12 weeks. Change in score is defined as total score at 12 weeks minus total score at baseline. The parent-proxy PEESS total score change from pre-treatment to post-treatment is the primary efficacy endpoint. 1FED vs 4FED changes are compared. A reduction in score (negative change) is indicative of a reduction in symptoms.

  Baseline and 12 weeks

• Within-group Comparisons (Baseline v. Week 12) of PEESS V2.0 Scores

  The PEESS V2.0 questionnaire captures EoE-specific symptoms. The range for PEESS v2.0 scores is 0 to 100, with a higher score being indicative of more frequent and/or severe symptoms. Baseline vs Week 12 scores are compared within each treatment group (1FED and 4FED).

  Baseline and 12 weeks

Secondary Outcomes (7)

• Percent of Participants in Histologic Remission (<15 Eosinophils Per High Power Field) at 12 Weeks

  12 weeks

• Percent of Participants on Swallowed Glucocorticoids (SGC) in Histologic Remission (<15 Eos/Hpf) at 12 Weeks in Phase 2

  12 weeks

• Percent of 1FED Non-responders on 4FED in Histologic Remission (<15 Eos/Hpf) at 12 Weeks in Phase 2

  12 weeks

• Change From Baseline in Pediatric Quality of Life Inventory Version 3.0 EoE Module (PedsQL 3.0 EoE) at 12 Weeks

  Baseline and 12 weeks

• Change From Baseline in Pediatric Quality of Life Inventory Version 4.0 (PedsQL 4.0) Generic Core Scales at 12 Weeks

  Baseline and 12 weeks

Study Arms (4)

1FED

ACTIVE COMPARATOR

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

Other: 1 Food Elimination Diet

4FED

ACTIVE COMPARATOR

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

Other: 4 Food Elimination Diet

1FED Non-Responders (4FED)

OTHER

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

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

4FED Non-Responders (SGC)

OTHER

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

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

Interventions

1 Food Elimination Diet OTHER

Participants eliminate milk from the diet for 12 weeks

Also known as: 1FED

1FED

4 Food Elimination Diet OTHER

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

Also known as: 4FED

4FED

4 Food Elimination Diet (post 1FED failure) 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

1FED Non-Responders (4FED)

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

4FED Non-Responders (SGC)

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

MeSH Terms

Conditions

Eosinophilic Esophagitis

Interventions

Fluticasone

Condition Hierarchy (Ancestors)

Esophagitis; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Gastroenteritis; Eosinophilia; Leukocyte Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Marc E. Rothenberg, MD, PhD
• Organization: Cincinnati Childrens Hospital Medical Center

Marc.Rothenberg@cchmc.org

513-636-7177

Study Officials

• Marc E Rothenberg, MD, PhD

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2015
• First Posted: November 20, 2015
• Study Start: March 21, 2016
• Primary Completion: May 16, 2018
• Study Completion: May 16, 2018
• Last Updated: August 27, 2018
• Results First Posted: July 18, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: After the associated research findings have been published, data will be made available for research purposes
• Access Criteria: Data will be provided in a form suitable for a variety of databases. Data will be provided to qualified individuals within the scientific community, according to federal guidelines.

Locations

US (1)