Health TrialsbyHealthPanel

Food Challenge at Home or in Medical Practice - the FoodCHOMP Study

ConditionFood Allergies
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAustin Health

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Negative (<3mm) fresh or extract skin testing to the food implicated within their allergy label

Aged greater than 18 years

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Home-Based Food Challenge

    Diagnostic test

    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.

  • In-Clinic Food Challenge

    Diagnostic test

    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.

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: In-Clinic Food Challenge (Control Arm)Other 1 intervention
Group B: Home-Based Food Challenge (Intervention Arm)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Proportion of participants experiencing immune-mediated adverse events during food challenge

Immune-mediated adverse events are defined as clinical symptoms consistent with IgE-mediated food allergy occurring during the food challenge, including but not limited to: urticaria, angioedema, vomiting, diarrhoea, or respiratory compromise (e.g., wheezing, cough, stridor). Events will be recorded according to a standardised adverse event form. For home challenges, participants will self-report symptoms daily and receive follow-up via nursing staff. In-clinic events will be recorded by supervising clinicians.

Time frame
During the food challenge period (Days 1-5 post-randomisation)

Secondary outcomes

1

Proportion of screened patients who are eligible for randomisation (Eligibility-to-screened ratio)

Feasibility metric defined as the proportion of patients referred to outpatient allergy clinic who meet the trial eligibility criteria (including negative skin prick testing to the implicated food and absence of exclusion criteria).

Time frame
Baseline visit
2

Proportion of eligible patients who consent to participate (Recruitment-to-eligibility ratio)

Feasibility of recruitment measured as the proportion of eligible patients who provide written informed consent to participate in the trial.

Time frame
At consent discussion (baseline visit)
3

Proportion of randomised participants who receive the allocated intervention (Intervention-to-recruitment ratio)

Defined as the proportion of randomised participants who complete their allocated food challenge (home or in-clinic) in accordance with protocol.

Time frame
Day 1 to Day 5 (intervention delivery period)
4

Proportion of participants experiencing non-immune mediated adverse events

Non-immune mediated events include those not consistent with IgE-mediated allergy and not meeting serious adverse event criteria. Examples: taste aversion, food refusal, procedural anxiety. Events will be recorded via self-report or in-clinic observation.

Time frame
Day 1 to Day 5 (challenge period)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Austin Health

Lead sponsor

Royal Melbourne Hospital, Australia

Collaborator

Source ClinicalTrials.gov
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