The Efficacy and Tolerability of 12-weeks Treatment With Almond and Buckwheat Based Formula in Pediatric Patients With Active EoE

Rambam Health Care Campus

Status: Enrolling

Conditions: Eosinophilic Esophagitis

Treatments: Dietary Supplement: Else nutrition formula

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05622214

0400-21-RMB

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 1 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Plant based nutrition

Experimental group

Description:

Plant based nutritional formula based on almond and buckwheat

Treatment:

Dietary Supplement: Else nutrition formula