The Efficacy and Tolerability of 12-weeks Treatment With... | NCT05622214

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

NCT05622214

Sponsor

Rambam Health Care Campus

Status

Unknown status

Last Update Posted

Nov 18, 2022Actual

Enrollment

20Estimated

Phase

Not Applicable

Conditions

Eosinophilic Esophagitis

Interventions

Else nutrition formula

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 25, 2022Actual

Primary Completion Date

Jul 24, 2023Estimated

Completion Date

Dec 31, 2023Estimated

First Submitted Date

Nov 14, 2022

First Submission Date that Met QC Criteria

Nov 14, 2022

First Posted Date

Nov 18, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 14, 2022

Last Update Posted Date

Nov 18, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ron Shaoul MD, Director, Pediatric Gastroenterology institute, Rambam Health Care CampusPrincipal Investigator

Lead Sponsor

Rambam Health Care CampusOTHER

Collaborators

Name	Class
Else Nutrition GH Ltd	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Plant based nutrition	Experimental	Plant based nutritional formula based on almond and buckwheat	Dietary Supplement: Else nutrition formula

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Else nutrition formula	Dietary Supplement	Plant based nutrition from almond and buckwheat	Plant based nutrition

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Year

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ron Shaoul, Dr.	Contact	+972-4-7774381		r_shaoul@rambam.health.gov.il
Liat Pritzker	Contact	+972-4-7774381		l_perel@rambam.health.gov.il

Overall Officials

Name	Affiliation	Role
Ron Shaoul, Dr.	Rambam Health Campus	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rambam Health Care Campus	Recruiting	Haifa			Israel

Condition Browse Module

MeSH Terms

ID	Term
D057765	Eosinophilic Esophagitis

Ancestor Terms

ID	Term
D004941	Esophagitis
D004935	Esophageal Diseases
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided