Phase 3
Completed N=63
Eosinophilic Esophagitis Intervention Trial-1 Food vs. 4 Food Elimination Diet Followed by Swallowed Glucocorticoids
Eosinophilic Esophagitis · Eosinophilic Gastrointestinal Disorders (EGIDs)
Source: ClinicalTrials.gov NCT02610816 ↗
Enrolled (actual)
63
Serious AEs
2.2%
Results posted
Jul 2018
Primary outcomePrimary: Change From Baseline in Pediatric EoE Symptom Score Version 2.0 (PEESS V2.0) at 12 Weeks — -14.3; -21.6 units on a scale — p=0.04
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Pediatric EoE Symptom Score Version 2.0 (PEESS V2.0) at 12 Weeks |
-14.3; -21.6 | 0.04 sig |
| PRIMARY Within-group Comparisons (Baseline v. Week 12) of PEESS V2.0 Scores |
38.1; 42.9; 23.5; 16.0 | <0.0001 sig |
| SECONDARY Percent of Participants in Histologic Remission (<15 Eosinophils Per High Power Field) at 12 Weeks |
20.6; 17.6; 23.5; 23.5; 44.1; 41.2 | 1.0 |
| SECONDARY Percent of Participants on Swallowed Glucocorticoids (SGC) in Histologic Remission (<15 Eos/Hpf) at 12 Weeks in Phase 2 |
25.0; 25.0; 50.0 | — |
| SECONDARY Percent of 1FED Non-responders on 4FED in Histologic Remission (<15 Eos/Hpf) at 12 Weeks in Phase 2 |
0; 12.5; 12.5 | — |
| SECONDARY Change From Baseline in Pediatric Quality of Life Inventory Version 3.0 EoE Module (PedsQL 3.0 EoE) at 12 Weeks |
71.3; 67.5; 9.7; 9.8 | 0.93 |
| SECONDARY Change From Baseline in Pediatric Quality of Life Inventory Version 4.0 (PedsQL 4.0) Generic Core Scales at 12 Weeks |
80.3; 79.9; 3.7; 5.3 | 0.74 |
| SECONDARY Change From Baseline in Endoscopic Reference Score at 12 Weeks |
2.5; 3.3; -0.7; -1.3 | 0.36 |
| SECONDARY Percent of Participants With Positive and Negative Milk Skin Prick Tests Responding to 1FED |
11; 89; 33; 48 | — |
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.
Data sourced from ClinicalTrials.gov (NCT02610816). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.