Eosinophilic Esophagitis Intervention Trial-1 Food vs. 4 Food Elimination Diet Followed by Swallo… (NCT02610816) | Clinical Trial Compass
CompletedPhase 2/3
Eosinophilic Esophagitis Intervention Trial-1 Food vs. 4 Food Elimination Diet Followed by Swallowed Glucocorticoids
United States67 participantsStarted 2016-03-21
Plain-language 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.
Who can participate
Age range6 Years – 17 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 pa…
What they're measuring
1
Change From Baseline in Pediatric EoE Symptom Score Version 2.0 (PEESS V2.0) at 12 Weeks
Timeframe: Baseline and 12 weeks
2
Within-group Comparisons (Baseline v. Week 12) of PEESS V2.0 Scores
Timeframe: Baseline and 12 weeks
Trial details
NCT IDNCT02610816
SponsorChildren's Hospital Medical Center, Cincinnati