Thresholds In Food Allergy evaluaTion And predictioN | NCT06038019

Studies
Thresholds In Food Allergy evaluaTion And predictioN

NCT06038019

Sponsor

Hamilton Health Sciences Corporation

Status

Recruiting

Last Update Posted

Jun 3, 2024Actual

Enrollment

2,000Estimated

Phase

Not provided

Conditions

Tree Nut Allergy
Food Allergy

Interventions

Oral food challenge

Countries

Canada

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 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 1, 2023Actual

Primary Completion Date

Nov 1, 2050Estimated

Completion Date

Jan 1, 2051Estimated

First Submitted Date

Aug 18, 2023

First Submission Date that Met QC Criteria

Sep 7, 2023

First Posted Date

Sep 14, 2023Actual

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

May 30, 2024

Last Update Posted Date

Jun 3, 2024Actual

Name	Class
AAAAI Foundation	UNKNOWN
Canadian Institutes of Health Research (CIHR)	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

Thresholds In food allergy evaluaTion And predictioN, a prospective, observational registry. The aim is to quantify food allergy thresholds in Canada and their clinical predictors.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Day

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group 1		Patients with suspected or confirmed food allergy	Diagnostic Test: Oral food challenge

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Oral food challenge	Diagnostic Test	Patients will undergo oral food challenge with increasing amounts of food allergen	Group 1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Eliciting dose thresholds to food challenge	Threshold are measured by controlled food challenge to incremental doses of allergen (g) and are adjudicated according to CoFAR v3.0 criteria	1 year

Secondary Outcomes

Measure	Description	Time Frame
Food Allergy Quality of Life Questionnaire Child Form	The number of items found in the child form questionnaire includes 30 items. Food allergy quality of life questionnaire is answered on a 7-point scale (0 to 6) with higher scores representing worse impairment.	1 year
Food Allergy Quality of Life Questionnaire Teen Form

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Suspicion or history of food allergy based on medical history, positive skin prick test, and/or serum food-specific IgE. A suggestive history is defined as typical clinical signs and/or symptoms (urticaria, angioedema, abdominal pain, vomiting, dyspnea, wheeze) within 60 minutes of the ingestion of a food.
Ability to discontinue all antihistamines for 1 week before oral food challenge.

Exclusion Criteria:

Previous desensitization treatment to a food allergen
Allergies to any component of the oral challenge vehicle
Unstable conditions including uncontrolled asthma or chronic urticaria
Any clinically significant disease/chronic medical condition which may interfere with study evaluations.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

3 Months

Maximum Age

65 Years

Standard Ages

ChildAdultOlder Adult

Study Population

All consecutive patients suspected or confirmed to be food allergic

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Heather Le	Contact	905-525-9140	75153	lehea@hhsc.ca

Overall Officials

Name	Affiliation	Role
Derek Chu, MD PhD FRCPC	Hamilton Health Sciences & McMaster University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
McMaster University Medical Centre	Recruiting	Hamilton	Ontario		Canada

IPD Sharing Statement Module

Plan to Share IPD

Description

Will consider on a case by case basis.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D021184	Nut Hypersensitivity
D005512	Food Hypersensitivity
D004194	Disease

Ancestor Terms

ID	Term
D000074924	Nut and Peanut Hypersensitivity
D006969	Hypersensitivity, Immediate
D006967	Hypersensitivity
D007154	Immune System Diseases

Browse Leaves

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Browse Branches

Not provided