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

Not Applicable

Recruiting

• Conditions: Eosinophilic Esophagitis
• Interventions: Dietary Supplement: Else nutrition formula

• Registration Number: NCT05622214
• Lead Sponsor: Rambam Health Care Campus

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-07-25
• Status Verified: 2022-11
• Study First Submitted: 2022-11-14
• Study First Submitted QC: 2022-11-14
• Last Update Submitted: 2022-11-14
• Study First Posted: 2022-11-18
• Last Update Posted: 2022-11-18
• Primary Completion: 2023-07-24
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Plant based nutrition	Else nutrition formula	Plant based nutritional formula based on almond and buckwheat

Primary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Rambam Health Care Campus; 🇮🇱 Haifa, Israel