Food Challenge at Home or in Medical Practice - a Multi-center Randomized Control Trial - FoodCHOMP Study

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

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

• Aged greater than 18 years

Locations
Other Locations
Australia
Austin Health
RECRUITING
Melbourne
Royal Melbourne Hospital
RECRUITING
Melbourne
Time Frame
Start Date: 2025-04-16
Estimated Completion Date: 2026-12-01
Participants
Target number of participants: 120
Treatments
Other: In-Clinic Food Challenge (Control Arm)
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.
Experimental: Home-Based Food Challenge (Intervention Arm)
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.
Related Therapeutic Areas
Sponsors
Collaborators: Royal Melbourne Hospital, Australia
Leads: Austin Health

This content was sourced from clinicaltrials.gov

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