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

Eosinophilic Esophagitis Clinical Trial

Official title:

An Open Label, Pilot Study Assessing the Efficacy and Tolerability of 12-weeks Treatment With Almond and Buckwheat Based Formula in Pediatric Patients With Active Eosinophilic Esophagitis (EoE)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05622214
• Other study ID #: 0400-21-RMB
• Status: Recruiting
• Phase: N/A
• Start date: July 25, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: November 2022
• Source: Rambam Health Care Campus
• Contact: Ron Shaoul, Dr.
• Phone: +972-4-7774381
• Email: r_shaoul[@]rambam.health.gov.il
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 31, 2023
• Est. primary completion date: July 24, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Eosinophilic Esophagitis
• Esophagitis

Intervention

Dietary Supplement:
• Else nutrition formula
Plant based nutrition from almond and buckwheat

Locations

Country	Name	City	State
Israel	Rambam Health Care Campus	Haifa

Sponsors (2)

Lead Sponsor	Collaborator
Rambam Health Care Campus	Else Nutrition GH Ltd

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in Pediatric Eosinophilic Esophagitis Symptom Severity Module (PEESS), endoscopic and histological scoring	Improvement in PEESS, endoscopic and histological scoring (assessed at week 0 and week 12)	12 weeks