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

Primary Purpose

Eosinophilic Esophagitis

Status

Recruiting

Phase

Not Applicable

Locations

Israel

Study Type

Interventional

Intervention

Else nutrition formula

About this trial

This is an interventional supportive care trial for Eosinophilic Esophagitis

Eligibility Criteria

1 Year - 18 Years (Child, Adult)All SexesDoes not accept 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

Sites / Locations

Rambam Health Care CampusRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Plant based nutrition

Arm Description

Plant based nutritional formula based on almond and buckwheat

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Full Information

NCT ID

NCT05622214

First Posted

November 14, 2022

Last Updated

November 14, 2022

Sponsor

Rambam Health Care Campus

Collaborators

Else Nutrition GH Ltd

1. Study Identification

Unique Protocol Identification Number

NCT05622214

Brief Title

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

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)

Study Type

Interventional

2. Study Status

Record Verification Date

November 2022

Overall Recruitment Status

Recruiting

Study Start Date

July 25, 2022 (Actual)

Primary Completion Date

July 24, 2023 (Anticipated)

Study Completion Date

December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Rambam Health Care Campus

Collaborators

Else Nutrition GH Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Eosinophilic Esophagitis

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Plant based nutrition

Arm Type

Experimental

Arm Description

Plant based nutritional formula based on almond and buckwheat

Intervention Type

Dietary Supplement

Intervention Name(s)

Else nutrition formula

Intervention Description

Plant based nutrition from almond and buckwheat

Primary Outcome Measure Information:

Title

Improvement in Pediatric Eosinophilic Esophagitis Symptom Severity Module (PEESS), endoscopic and histological scoring

Description

Improvement in PEESS, endoscopic and histological scoring (assessed at week 0 and week 12)

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

1 Year

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ron Shaoul, Dr.

Phone

+972-4-7774381

r_shaoul@rambam.health.gov.il

First Name & Middle Initial & Last Name or Official Title & Degree

Liat Pritzker

Phone

+972-4-7774381

l_perel@rambam.health.gov.il

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ron Shaoul, Dr.

Organizational Affiliation

Rambam Health Campus

Official's Role

Principal Investigator

Facility Information:

Facility Name

Rambam Health Care Campus

City

Haifa

Country

Israel

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ron Shaoul, Dr.

Phone

+972-4-7774381

r_shaoul@rambam.health.gov.il

12. IPD Sharing Statement

Learn more about this trial

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

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