The Efficacy and Tolerability of 12-weeks Treatment With Almond and Buckwheat Based Formula in Pediatric Patients With Active EoE
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)
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 25, 2022
CompletedFirst Submitted
Initial submission to the registry
November 14, 2022
CompletedFirst Posted
Study publicly available on registry
November 18, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 24, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2023
CompletedNovember 18, 2022
November 1, 2022
12 months
November 14, 2022
November 14, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
Plant based nutrition
EXPERIMENTALPlant based nutritional formula based on almond and buckwheat
Interventions
Plant based nutrition from almond and buckwheat
Eligibility Criteria
You may qualify if:
- Pediatric patients with active EoE (naïve and experienced)
- Ages 1-18 years
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Rambam Health Care Campuslead
- Else Nutrition GH Ltdcollaborator
Study Sites (1)
Rambam Health Care Campus
Haifa, Israel
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ron Shaoul, Dr.
Rambam Health Campus
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director, Pediatric Gastroenterology institute
Study Record Dates
First Submitted
November 14, 2022
First Posted
November 18, 2022
Study Start
July 25, 2022
Primary Completion
July 24, 2023
Study Completion
December 31, 2023
Last Updated
November 18, 2022
Record last verified: 2022-11