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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02610816
• Date of registration: 12/10/2015
• Prospective Registration: Yes
• Primary sponsor: Children's Hospital Medical Center, Cincinnati
• Public title: Eosinophilic Esophagitis Intervention Trial-1 Food vs. 4 Food Elimination Diet Followed by Swallowed Glucocorticoids
• Scientific title: Eosinophilic Esophagitis (EoE) Intervention Trial-Randomized 1 Food Elimination vs. 4 Food Elimination Diet Followed by Swallowed Glucocorticoids
• Date of first enrolment: March 21, 2016
• Target sample size: 67
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02610816
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2/Phase 3

Countries of recruitment

United States

Contacts

• Name: Marc E Rothenberg, MD, PhD
• Affiliation: Children's Hospital Medical Center, Cincinnati

Key inclusion & exclusion 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 (ß-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.



Age minimum: 6 Years
Age maximum: 17 Years
Gender: All

Health Condition(s) or Problem(s) studied

Eosinophilic Gastrointestinal Disorders (EGIDs)

Eosinophilic Esophagitis

Intervention(s)

Other: 4 Food Elimination Diet

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

Other: 1 Food Elimination Diet

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

Primary Outcome(s)

Change From Baseline in Pediatric EoE Symptom Score Version 2.0 (PEESS V2.0) at 12 Weeks [Time Frame: Baseline and 12 weeks]

Within-group Comparisons (Baseline v. Week 12) of PEESS V2.0 Scores [Time Frame: Baseline and 12 weeks]

Secondary Outcome(s)

Percent of Participants in Histologic Remission (<15 Eosinophils Per High Power Field) at 12 Weeks [Time Frame: 12 weeks]

Percent of 1FED Non-responders on 4FED in Histologic Remission (<15 Eos/Hpf) at 12 Weeks in Phase 2 [Time Frame: 12 weeks]

Change From Baseline in Pediatric Quality of Life Inventory Version 4.0 (PedsQL 4.0) Generic Core Scales at 12 Weeks [Time Frame: Baseline and 12 weeks]

Change From Baseline in Endoscopic Reference Score at 12 Weeks [Time Frame: Baseline and 12 weeks]

Change From Baseline in Pediatric Quality of Life Inventory Version 3.0 EoE Module (PedsQL 3.0 EoE) at 12 Weeks [Time Frame: Baseline and 12 weeks]

Percent of Participants on Swallowed Glucocorticoids (SGC) in Histologic Remission (<15 Eos/Hpf) at 12 Weeks in Phase 2 [Time Frame: 12 weeks]

Percent of Participants With Positive and Negative Milk Skin Prick Tests Responding to 1FED [Time Frame: Baseline and 12 weeks]

Secondary ID(s)

2015-2187

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Patient-Centered Outcomes Research Institute

Results

• Results available: Yes
• Date Posted: 18/07/2018
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02610816