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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-25

Study Completion Date

2023-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Eosinophilic Esophagitis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Plant based nutrition

Plant based nutritional formula based on almond and buckwheat

Group Type EXPERIMENTAL

Else nutrition formula

Intervention Type DIETARY_SUPPLEMENT

Plant based nutrition from almond and buckwheat

Interventions

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Else nutrition formula

Plant based nutrition from almond and buckwheat

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

1 Year

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No