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NCT05622214
The Efficacy and Tolerability of 12-weeks Treatment With Almond and Buckwheat Based Formula in Pediatric Patients With Active EoE
Conditions: Eosinophilic Esophagitis
Sex: All
Ages: 1 Year – 18 Years
Phase: NA
Enrollment: 20
Sponsor: Rambam Health Care Campus
Location: Israel
Summary
Eosinophilic esophagitis (EoE) is a chronic, relapsing, immune-mediated esophageal disease.
Clinical manifestations in infants and toddlers generally include vomiting, food refusal, choking with meals and, less commonly, failure to thrive.
The management of the disease includes dietary and pharmaceutical interventions, and the goal of the treatment should ideally be both the resolution of symptoms and the normalization of the macroscopic and microscopic abnormalities.
Milk is the most common food trigger identified, followed by wheat, soy, and eggs.
The aim of the study is to examine the tolerability of a new plant based formula made of minimally processed almond and buckwheat and enriched with vitamins and minerals.
Eligibility Criteria
Inclusion Criteria:Pediatric patients with active EoE (naïve and experienced)Ages 1-18 yearsExclusion Criteria:Change in dosing of Proton pump inhibitors (PPI) medicationLocal steroid treatment < 1 monthRefusal to comply with study protocolKnown allergy to almonds and buckwheatUse of dairy during the study
Source: ClinicalTrials.gov (NCT05622214). StuddyBuddy aggregates publicly available trial information.