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

Overview

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.

Interventions

• Diagnostic test Home-Based Food Challenge
  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 rea
• Diagnostic test In-Clinic Food Challenge
  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 anaphyl

Primary outcome measures

• Proportion of participants experiencing immune-mediated adverse events during food challenge [Time frame: During the food challenge period (Days 1-5 post-randomisation)]

Secondary outcome measures (9)

• Proportion of screened patients who are eligible for randomisation (Eligibility-to-screened ratio) [Time frame: Baseline visit]
• Proportion of eligible patients who consent to participate (Recruitment-to-eligibility ratio) [Time frame: At consent discussion (baseline visit)]
• Proportion of randomised participants who receive the allocated intervention (Intervention-to-recruitment ratio) [Time frame: Day 1 to Day 5 (intervention delivery period)]
• Proportion of participants experiencing non-immune mediated adverse events [Time frame: Day 1 to Day 5 (challenge period)]
• Proportion of participants with severe adverse reactions (anaphylaxis or death) [Time frame: Day 1 to Day 5 (challenge period)]
• Difference in proportion of participants tolerant to challenge food [Time frame: At completion of challenge (Day 5)]
• Change in Food Allergy Quality of Life (FAQLQ-12) score from baseline [Time frame: Baseline and 6 months post-randomisation]
• Proportion of participants consuming the challenge food post-trial [Time frame: At 6-month follow-up]
• Time from clinic referral to challenge completion [Time frame: From the date of referral for food challenge to date of challenge completion or withdrawal from the study assessed up to 60 months.]

Eligibility criteria

Inclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Diagnostic

Study locations

Australia · 2 centers

• Austin Health — Melbourne
• Royal Melbourne Hospital — Melbourne

Publications

• Godsell J, Vogrin S, Chan S, Henri M, Ng I, Andrews E, Spriggs K, Perrett KP, Trubiano J. FoodCHOMP (Food Challenge-at HOme or in Medical Practice): a pilot multicentre randomised controlled trial evaluating home versus clinic-based food allergy challenges in low-risk adults-study protocol. BMJ Open. 2026 Feb 6;16(2):e114483. doi: 10.1136/bmjopen-2025-114483. PMID 41651530

Identifiers

NCT: NCT06916819 · 111750/Austin-2024

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗