Clinical trial NCT06916819: Food Challenge at Home or in Medical Practice - the FoodCHOMP Study
Official title: Food Challenge at Home or in Medical Practice - a Multi-center Randomized Control Trial - FoodCHOMP Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Food Allergies
Keywords: Food allergy
Food allergy label
Food Challenge
Lead sponsor: Austin Health
Sponsor class: OTHER_GOV
Collaborators: name: Royal Melbourne Hospital, Australia
First posted: 2025-04-08
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study uses a parallel assignment model. Participants who meet eligibility criteria are randomly assigned in a 1:1 ratio to one of two arms: a home-based food challenge group (intervention) or a standard in-clinic food challenge group (control). Each participant undergoes only one of the two interventions, and there is no crossover between arms. Randomisation is stratified by site and gender and conducted via REDCap using a permuted block design.
Primary purpose: DIAGNOSTIC

Brief 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.

Detailed description: Food allergies are highly prevalent and contribute to significant patient anxiety and healthcare utilisation. Many individuals carry food allergy labels without confirmation through diagnostic food challenge, resulting in unnecessary food avoidance. In-clinic food challenges are the current standard for confirming tolerance but are resource-intensive and often delayed. This study evaluates whether selected low-risk adults can safely complete a structured oral food challenge at home.

This is a pilot, multi-centre, randomised controlled trial conducted at two tertiary allergy centres in Victoria, Australia (Austin Health and Royal Melbourne Hospital). Adults referred with a reported food allergy will undergo clinical assessment and skin prick testing. Those with negative skin testing (\<3mm wheal) to the implicated food and meeting other eligibility criteria will be randomised 1:1 to either:

* Intervention: Home-based oral food challenge over five days, beginning with a single supervised dose in-clinic and followed by four incremental doses at home with daily clinical follow-up.
* Control: Standard in-clinic oral food challenge using a protocol derived from PRACTALL and ASCIA guidelines.

The primary outcome is the proportion of participants experiencing an immune-mediated adverse event during food challenge. Secondary outcomes include feasibility metrics (eligibility, recruitment, delivery), non-immune mediated adverse events, protocol adherence, quality of life (measured by FAQLQ-12), time to challenge, and real-world food reintroduction.

The study will enrol 120 participants (60 per arm). Outcomes will inform the design of a future non-inferiority trial and may support integration of home challenges into routine practice for selected patients.

Eligibility criteria: Inclusion Criteria:

1. Negative (\<3mm) fresh or extract skin testing to the food implicated within their allergy label
2. Aged greater than 18 years

Exclusion Criteria:

* 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

Primary outcomes:
measure: Proportion of participants experiencing immune-mediated adverse events during food challenge
timeFrame: During the food challenge period (Days 1-5 post-randomisation)
Secondary outcomes:
measure: Proportion of screened patients who are eligible for randomisation (Eligibility-to-screened ratio)
timeFrame: Baseline visit
measure: Proportion of eligible patients who consent to participate (Recruitment-to-eligibility ratio)
timeFrame: At consent discussion (baseline visit)
measure: Proportion of randomised participants who receive the allocated intervention (Intervention-to-recruitment ratio)
timeFrame: Day 1 to Day 5 (intervention delivery period)
measure: Proportion of participants experiencing non-immune mediated adverse events
timeFrame: Day 1 to Day 5 (challenge period)
measure: Proportion of participants with severe adverse reactions (anaphylaxis or death)
timeFrame: Day 1 to Day 5 (challenge period)
measure: Difference in proportion of participants tolerant to challenge food
timeFrame: At completion of challenge (Day 5)
measure: Change in Food Allergy Quality of Life (FAQLQ-12) score from baseline
timeFrame: Baseline and 6 months post-randomisation
measure: Proportion of participants consuming the challenge food post-trial
timeFrame: At 6-month follow-up
measure: Time from clinic referral to challenge completion
timeFrame: From the date of referral for food challenge to date of challenge completion or withdrawal from the study assessed up to 60 months.
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Austin Health
state: Victoria
city: Melbourne
country: Australia
facility: Royal Melbourne Hospital
state: Victoria
Study officials:
References: