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

NCT06916819 | Recruiting

• 1 other identifier: 111750/Austin-2024
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

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.

Conditions

Food Allergies

Keywords

Food allergy; Food allergy label; Food Challenge

Outcome Measures

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.

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

Secondary Outcomes (9)

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

  Baseline visit

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

  At consent discussion (baseline visit)

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

  Day 1 to Day 5 (intervention delivery period)

• Proportion of participants experiencing non-immune mediated adverse events

  Day 1 to Day 5 (challenge period)

• Proportion of participants with severe adverse reactions (anaphylaxis or death)

  Day 1 to Day 5 (challenge period)

Study Arms (2)

In-Clinic Food Challenge (Control Arm)

OTHER

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.

Diagnostic Test: In-Clinic Food Challenge

Home-Based Food Challenge (Intervention Arm)

EXPERIMENTAL

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.

Diagnostic Test: Home-Based Food Challenge

Interventions

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.

Home-Based Food Challenge (Intervention Arm)

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.

In-Clinic Food Challenge (Control Arm)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Austin Health: lead
• Royal Melbourne Hospital, Australia: collaborator

Study Sites (2)

Austin Health

Melbourne, Victoria, Australia

RECRUITING

Royal Melbourne Hospital

Melbourne, Victoria, Australia

RECRUITING

MeSH Terms

Conditions

Food Hypersensitivity

Condition Hierarchy (Ancestors)

Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr Jack Godsell, Clinical Immunologist and Allergist, Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: March 26, 2025
• First Posted: April 8, 2025
• Study Start: April 16, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 17, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

AU (2)