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Status unknownNCT05622214Updated Nov 18, 2022

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

An interventional study of Else nutrition formula in Eosinophilic Esophagitis, sponsored by Rambam Health Care Campus. Status unknown at 1 site in Israel. Open to participants aged 1 Year to 18 Years. Per ClinicalTrials.gov, last updated 2022-11-18.

Sponsored by Rambam Health Care Campus · Not applicable, Interventional, and Supportive care

The sponsor has not verified this record recently (last verified Nov 2022), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled Jul 2022, registered Nov 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
1 Year to 18 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Eosinophilic Esophagitis
03

In context

Esophagitis

322 studies on the registry are indexed under Esophagitis; 37 are open to participants now.

This study's planned enrollment of 20 is below the median of 66 across 215 interventional studies indexed under Esophagitis.

Browse Esophagitis studies →

Lead sponsor

Rambam Health Care Campus is the lead sponsor of 456 studies on the registry; 33 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Year to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Pediatric patients with active EoE (naïve and experienced)
  • Ages 1-18 years

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    Plant based nutrition

    Plant based nutritional formula based on almond and buckwheat

    Dietary Supplement: Else nutrition formula

Interventions

  • Dietary supplementElse nutrition formula

    Plant based nutrition from almond and buckwheat

06

What researchers measure

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)

    Time frame: 12 weeks

07

Study locations

1 of 1 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 18, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05622214
Lead sponsor
Rambam Health Care Campus
Collaborators
Else Nutrition GH Ltd
Responsible party
Ron Shaoul MD (Director, Pediatric Gastroenterology institute, Rambam Health Care Campus) — Principal investigator
First posted
Nov 18, 2022
Start date
Jul 25, 2022
Primary completion
Jul 24, 2023 (estimated)
Completion
Dec 31, 2023 (estimated)
Last update
Nov 18, 2022

Study contacts

Ron Shaoul, Dr.
Contact
r_shaoul@rambam.health.gov.il
+972-4-7774381
Liat Pritzker
Contact
l_perel@rambam.health.gov.il
+972-4-7774381
Ron Shaoul, Dr.
principal investigator · Rambam Health Campus

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.

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