Allergy to Almond in Children | NCT04407104

Studies
Allergy to Almond in Children

NCT04407104

Sponsor

Central Hospital, Nancy, France

Status

Unknown status

Last Update Posted

Jul 21, 2020Actual

Enrollment

50Estimated

Phase

Not provided

Conditions

Food Allergy in Children

Interventions

skin prick-test

Countries

Not provided

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

May 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 20, 2020Estimated

Primary Completion Date

Aug 31, 2020Estimated

Completion Date

Sep 7, 2020Estimated

First Submitted Date

May 25, 2020

First Submission Date that Met QC Criteria

May 25, 2020

First Posted Date

May 29, 2020Actual

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

Jul 20, 2020

Last Update Posted Date

Jul 21, 2020Actual

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

Allergy to tree nuts are frequent in children but allergy to almond is one of the less described tree nuts allergy. The main objective of our study is to determine diagnostic values of skin prick-tests and specific IgE to almond in a population of children sensitized to almond and challenged in our unit from november 2013 to march 2020.

Detailed Description

Secondary objectives are

description of allergic reactions to almond (symptoms, severity)
modelisation of eliciting dose to almond in our population
evaluation of the association between atopic comorbidities and allergy to almond in children sensitized to almond
evaluation of the association between allergy to almond and the importance of skin and sIgE sensitization

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
skin prick-test	Diagnostic Test	retrospective study on data already collected		specific IgE oral food challenge

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
diagnostic values of skin prick-test and sIgE to almond		BASELINE

Secondary Outcomes

Measure	Description	Time Frame
allergic reactions during oral food challenge	symptoms and severity	BASELINE
eliciting doses to almond	ED05, ED10 and ED50	BASELINE

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

oral food challenge to almond performed in the pediatric allergy department of the University Hospital of Nancy from november 2013 and march 2020

Exclusion Criteria:

doubtful or incomplete oral food challenge to almond

Accepts Healthy Volunteers

Not provided

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

children sensitized to almond and challenged in our unit

Sampling Method

Non-Probability Sample

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006967	Hypersensitivity

Ancestor Terms

ID	Term
D007154	Immune System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D010328	Patch Tests

Ancestor Terms

ID	Term
D012882	Skin Tests
D007159	Immunologic Tests
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures

Browse Leaves

Not provided

Browse Branches

Not provided