The Efficacy and Tolerability of 12-weeks Treatment With Almond and Buckwheat Based Formula in Pediatric Patients With Active EoE
NCT05622214 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2022-11-18
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.
Conditions
- Eosinophilic Esophagitis
Interventions
- DIETARY_SUPPLEMENT
-
Else nutrition formula
Plant based nutrition from almond and buckwheat
Sponsors & Collaborators
-
Else Nutrition GH Ltd
collaborator INDUSTRY -
Rambam Health Care Campus
lead OTHER
Principal Investigators
-
Ron Shaoul, Dr. · Rambam Health Campus
Study Design
- Allocation
- NA
- Purpose
- SUPPORTIVE_CARE
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 1 Year
- Max Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-07-25
- Primary Completion
- 2023-07-24
- Completion
- 2023-12-31
Countries
- Israel
Study Locations
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