Food Challenge at Home or in Medical Practice - the FoodCHOMP Study
Food Challenge at Home or in Medical Practice - a Multi-center Randomized Control Trial - FoodCHOMP Study
Austin Health
120 participants
Apr 16, 2025
INTERVENTIONAL
Conditions
Summary
This is a pilot, multi-centre, randomised clinical trial evaluating the safety and feasibility of a home-based oral food challenge in adults with low-risk food allergy labels. Eligible participants are aged 18 years or older and have a self-reported food allergy with negative skin prick testing to the implicated food. Participants will be randomised to either a home-based or standard in-clinic food challenge. The primary aim is to determine the safety of home challenges, measured by the rate of immune-mediated adverse events. Secondary aims include feasibility of recruitment and delivery, protocol adherence, quality of life, and food reintroduction outcomes.
Eligibility
Inclusion Criteria2
- Negative (<3mm) fresh or extract skin testing to the food implicated within their allergy label
- Aged greater than 18 years
Exclusion Criteria8
- Evidence of prior sensitisation to challenge food 0 Defined as previously positive skin testing or allergen specific IgEs if available
- Pregnancy
- Patients with poorly controlled asthma - defined as an ACQ5 scores >1 at the time of enrolment
- Patients with a history of food reactions that is not-consistent with an IgE mediated process; i.e. exclusively gastrointestinal symptoms, FPIES
- Patients with a clear history of food-dependent exercise induced anaphylaxis
- Patients on a concurrent medication which may influence the outcome of the challenge;
- Antihistamine therapy; Patients receiving more than stress dose steroids (i.e. > 50mg QID hydrocortisone \[or steroid equivalent\]); Omalizumab
- Any other illness that, in the investigator's judgement, will substantially increase the risk associated with subject's participation in this study
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Interventions
Participants randomised to the intervention arm will undertake a structured home-based oral food challenge over five consecutive days. This begins with an initial supervised dose administered in clinic under medical observation (60-minute monitoring period). Participants will then self-administer increasing doses of the implicated food at home each subsequent day using a standardised protocol adapted from PRACTALL and ASCIA guidelines. Dose intervals are 24 hours to reduce risk of cumulative reactions. Participants are provided with written instructions, emergency action plans, and have daily phone follow-up with allergy nursing staff during the challenge. The challenge food is selected by the participant from their eligible food allergy labels.
Standard of care - Participants randomised to the control arm will undergo a standard in-clinic oral food challenge conducted under direct medical supervision. The protocol used is derived from the PRACTALL consensus and ASCIA position statements and involves administration of increasing doses of the implicated food at 20-30 minute intervals over a 2-3 hour period. Observation continues for 1-2 hours post final dose. The challenge is performed in a hospital outpatient clinic equipped for anaphylaxis management. The food challenged is selected by the participant from their eligible food allergy labels.
Locations(2)
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NCT06916819