Eosinophilic Esophagitis
Conditions
Brief 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.
Interventions
DIETARY_SUPPLEMENTElse nutrition formula
Plant based nutrition from almond and buckwheat
Sponsors
Else Nutrition GH Ltd
Rambam Health Care Campus
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* Pediatric patients with active EoE (naïve and experienced) * Ages 1-18 years
Exclusion criteria
* Change in dosing of Proton pump inhibitors (PPI) medication * Local steroid treatment \< 1 month * Refusal to comply with study protocol * Known allergy to almonds and buckwheat * Use of dairy during the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in Pediatric Eosinophilic Esophagitis Symptom Severity Module (PEESS), endoscopic and histological scoring | 12 weeks | Improvement in PEESS, endoscopic and histological scoring (assessed at week 0 and week 12) |
Countries
Israel
Contacts
Primary ContactRon Shaoul, Dr.
Backup ContactLiat Pritzker
Outcome results
None listed