Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12625001208493
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
12/09/2025
Date registered
Help: Date registered
31/10/2025
Date last updated
Help: Date last updated
11/06/2026
Date data sharing statement initially provided
Help: Data sharing statement date
31/10/2025
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
Food Allergy Care and Outcomes in Adolescents (the FOCUS study) : Evaluating the Role of Oral Food Challenges in de-labelling food allergies and improving quality of life.
Scientific title
Food Allergy Care and Outcomes in Adolescents (the FOCUS study) : Evaluating the Role of Oral Food Challenges in de-labelling food allergies and improving quality of life.
Additional trial identifiers [1] 314113 0
Nil
Universal Trial Number (UTN)
Trial acronym
FOCUS
Related trial records

Health condition
Health condition(s) studied:
Food Allergy 336914 0
Condition category
Condition code
Inflammatory and Immune System 333379 333379 0 0
Allergies
Mental Health 335422 335422 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
Oral food challenges will be offered to eligible food allergic adolescents aged 15-17 years. The participant will be admitted to the study site on the day of the food challenge, and the challenge will usually take 4 to 6 hours to complete.
Prior to the food challenge, a physical examination, blood and skin prick testing will take place.
Oral food challenges involve giving increasing amounts of the allergic food every 20 to 30 minutes. The challenge starts with tiny amounts and watching to see if a reaction occurs. The adolescent will be monitored by an allergy trained nurse and an allergy trained medical doctor or nurse practitioner will supervise.
Regular monitoring including vital signs (e.g. pulse, blood pressure) will take place. Depending on the number of food allergies the adolescent has, they may be eligible for up to three food challenges. Eligible foods include egg, cow's milk, peanut and tree nuts.
The dosing schedules will be standardised across all sites and will depend on the allergen being challenged.
The order and timing of challenges will be made in consultation between the adolescent, their family, and the doctors and nurses involved.
Intervention code [1] 330688 0
Diagnosis / Prognosis
Description of the comparator or control
Adolescents that are either ineligible or refuse an oral food challenge, will continue on the standard care pathway (allergen avoidance) and complete study questionnaires.
Control group
Active

Outcomes
Primary outcome [1] 340948 0
The proportion of food allergies that are “delabelled” (no longer considered food allergic)
Timepoint [1] 340948 0
At completion of the oral food challenge/s
Primary outcome [2] 340949 0
Change in self-reported questionnaire measures of food allergy anxiety (adolescent)
Timepoint [2] 340949 0
Baseline [all participants] and at 12 months for participants that remain food allergic [post recruitment in questionnaire only group or following completion of food challenges].
Primary outcome [3] 340950 0
Change in self-reported questionnaire measures of food allergy quality of life (adolescent)
Timepoint [3] 340950 0
Baseline [all participants] and at 12 months for participants that remain food allergic [post recruitment in questionnaire only group or following completion of food challenges].
Secondary outcome [1] 445559 0
Change in self-reported questionnaire measures of confidence in managing food allergy (adolescent)
Timepoint [1] 445559 0
Baseline [all participants] and at 12 months for participants that remain food allergic [post recruitment in questionnaire only group or following completion of food challenges].
Secondary outcome [2] 445560 0
Changes in self-reported food allergy risk-taking behaviours (adolescent)
Timepoint [2] 445560 0
Baseline [all participants] and at 12 months for participants that remain food allergic [post recruitment in questionnaire only group or following completion of food challenges].
Secondary outcome [3] 445561 0
The proportion of adolescents who agree to have an oral food challenge and reasons for declining oral food challenge
Timepoint [3] 445561 0
At study completion
Secondary outcome [4] 446499 0
Accuracy of allergen sensitization tests (skin prick testing) for predicting oral food challenge outcomes.
Timepoint [4] 446499 0
At study completion
Secondary outcome [5] 451527 0
Accuracy of biomarkers (blood tests) for predicting oral food challenge outcomes.
Timepoint [5] 451527 0
At study completion
Secondary outcome [6] 451528 0
Direct and indirect costs of implementing OFCs for adolescents with food allergy. This will be assessed as a composite outcome.
Timepoint [6] 451528 0
At study completion
Secondary outcome [7] 453077 0
Change in self-reported questionnaire measures of anxiety (adolescent) (Primary Outcome).
Timepoint [7] 453077 0
Baseline [all participants] and at 12 months [post recruitment in questionnaire only group or following completion of food challenges].
Secondary outcome [8] 453081 0
Change in self-reported questionnaire measures of quality of life (adolescent) (Primary Outcome)
Timepoint [8] 453081 0
Baseline, on the day of oral food challenge, and at 3 and 12 months [post recruitment in questionnaire only group or following completion of food challenges].

Eligibility
Key inclusion criteria
History of diagnosed IgE food allergy or anaphylaxis (reaction history and positive tests of sensitisation), or history of sensitization (SPT >3mm or sIgE >0.35kU/L) and long-term avoidance, to peanut, egg, milk, or tree nut/s
Minimum age
15 Years
Maximum age
17 Years
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
Parent/guardian unable to provide informed consent.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/01/2026
Actual
18/05/2026
Date of last participant enrolment
Anticipated
30/06/2029
Actual
Date of last data collection
Anticipated
31/12/2029
Actual
Sample size
Target
300
Accrual to date
1
Final
Recruitment in Australia
Recruitment state(s)
QLD,WA,VIC
Recruitment hospital [1] 27688 0
Queensland Children's Hospital - South Brisbane
Recruitment hospital [2] 27689 0
The Royal Childrens Hospital - Parkville
Recruitment hospital [3] 27690 0
Perth Children's Hospital - Nedlands
Recruitment postcode(s) [1] 43876 0
4101 - South Brisbane
Recruitment postcode(s) [2] 43877 0
3052 - Parkville
Recruitment postcode(s) [3] 43878 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 318620 0
Government body
Name [1] 318620 0
National Health and Medical Research Council
Country [1] 318620 0
Australia
Primary sponsor type
University
Name
The University of Queenlsand
Address
Country
Australia
Secondary sponsor category [1] 321027 0
None
Name [1] 321027 0
None
Address [1] 321027 0
Country [1] 321027 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317223 0
Children’s Health Queensland Hospital and Health Service Human Research Ethics Committee
Ethics committee address [1] 317223 0
Ethics committee country [1] 317223 0
Australia
Date submitted for ethics approval [1] 317223 0
10/01/2025
Approval date [1] 317223 0
13/02/2025
Ethics approval number [1] 317223 0
HREC/2024/QCHQ/115577

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 140398 0
A/Prof Jennifer Koplin
Address 140398 0
Centre for Children's Health Research. 62 Graham Street, South Brisbane, QLD 4101
Country 140398 0
Australia
Phone 140398 0
+61 730697411
Fax 140398 0
Email 140398 0
[email protected]
Contact person for public queries
Name 140399 0
Jennifer Koplin
Address 140399 0
Centre for Children's Health Research. 62 Graham Street, South Brisbane, QLD 4101
Country 140399 0
Australia
Phone 140399 0
+61 730697411
Fax 140399 0
Email 140399 0
[email protected]
Contact person for scientific queries
Name 140400 0
Jennifer Koplin
Address 140400 0
Centre for Children's Health Research. 62 Graham Street, South Brisbane, QLD 4101
Country 140400 0
Australia
Phone 140400 0
+61 730697411
Fax 140400 0
Email 140400 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No



What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.