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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.

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.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12625001208493
Acronym
FOCUS
Enrollment
1
Registered
2025-10-31
Start date
2026-05-18
Completion date
2029-06-30
Last updated
2026-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Oral food challenges (OFC) are the gold standard tool for diagnosis of allergy and acquisition of tolerance but are not routinely performed in adolescents. These have the potential to positively impact mental health, quality of life and reduce risk-taking behaviours, in addition to ensuring accurate diagnosis. We will undertake a multi-centre prospective study of adolescents with a previous diagnosis of food allergy to investigate the impact of oral food challenges on the proportion of adolescents who enter adulthood with a current food allergy diagnosis (and proportion who were “de-labelled” i.e. proven to be no longer allergic) and impact on anxiety, quality of life, confidence in managing food allergy and risk-taking behaviours. We hypothesise that using OFCs for adolescents at the time of transition to adult care will reduce the number of adolescents entering adulthood with a food allergy diagnosis, reduce risk taking behaviours, psychological impact and costs for patients, families and the healthcare system.

Interventions

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

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.

Sponsors

The University of Queenlsand
Lead SponsorUniversity

Study design

Allocation
Non-randomised trial
Primary purpose
Diagnosis
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
15 Years to 17 Years
Healthy volunteers
No

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

Exclusion criteria

Parent/guardian unable to provide informed consent.

Outcome results

None listed

Source: ANZCTR · Data processed: Jun 21, 2026