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

NARecruitingINTERVENTIONAL
Enrollment

120

Participants

Timeline

Start Date

April 16, 2025

Primary Completion Date

July 1, 2026

Study Completion Date

December 1, 2026

Conditions
Food Allergies
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 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

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 anaphylaxis management. The food challenged is selected by the participant from their eligible food allergy labels.

Trial Locations (2)

Unknown

RECRUITING

Austin Health, Melbourne

RECRUITING

Royal Melbourne Hospital, Melbourne

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Royal Melbourne Hospital, Australia

UNKNOWN

lead

Austin Health

OTHER_GOV

NCT06916819 - Food Challenge at Home or in Medical Practice - the FoodCHOMP Study | Biotech Hunter | Biotech Hunter