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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06916819




Registration number
NCT06916819
Ethics application status
Date submitted
26/03/2025
Date registered
8/04/2025

Titles & IDs
Public title
Food Challenge at Home or in Medical Practice - the FoodCHOMP Study
Scientific title
Food Challenge at Home or in Medical Practice - a Multi-center Randomized Control Trial - FoodCHOMP Study
Secondary ID [1] 0 0
111750/Austin-2024
Universal Trial Number (UTN)
Trial acronym
CHOMP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Food Allergies 0 0
Condition category
Condition code
Inflammatory and Immune System 0 0 0 0
Allergies

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Diagnosis / Prognosis - Home-Based Food Challenge
Diagnosis / Prognosis - In-Clinic Food Challenge

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.


Diagnosis / Prognosis: 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.

Diagnosis / Prognosis: 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.
Intervention code [1] 0 0
Diagnosis / Prognosis
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of participants experiencing immune-mediated adverse events during food challenge
Timepoint [1] 0 0
During the food challenge period (Days 1-5 post-randomisation)
Secondary outcome [1] 0 0
Proportion of screened patients who are eligible for randomisation (Eligibility-to-screened ratio)
Timepoint [1] 0 0
Baseline visit
Secondary outcome [2] 0 0
Proportion of eligible patients who consent to participate (Recruitment-to-eligibility ratio)
Timepoint [2] 0 0
At consent discussion (baseline visit)
Secondary outcome [3] 0 0
Proportion of randomised participants who receive the allocated intervention (Intervention-to-recruitment ratio)
Timepoint [3] 0 0
Day 1 to Day 5 (intervention delivery period)
Secondary outcome [4] 0 0
Proportion of participants experiencing non-immune mediated adverse events
Timepoint [4] 0 0
Day 1 to Day 5 (challenge period)
Secondary outcome [5] 0 0
Proportion of participants with severe adverse reactions (anaphylaxis or death)
Timepoint [5] 0 0
Day 1 to Day 5 (challenge period)
Secondary outcome [6] 0 0
Difference in proportion of participants tolerant to challenge food
Timepoint [6] 0 0
At completion of challenge (Day 5)
Secondary outcome [7] 0 0
Change in Food Allergy Quality of Life (FAQLQ-12) score from baseline
Timepoint [7] 0 0
Baseline and 6 months post-randomisation
Secondary outcome [8] 0 0
Proportion of participants consuming the challenge food post-trial
Timepoint [8] 0 0
At 6-month follow-up
Secondary outcome [9] 0 0
Time from clinic referral to challenge completion
Timepoint [9] 0 0
From the date of referral for food challenge to date of challenge completion or withdrawal from the study assessed up to 60 months.

Eligibility
Key inclusion criteria
1. Negative (<3mm) fresh or extract skin testing to the food implicated within their allergy label
2. Aged greater than 18 years
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
16/04/2025
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2026
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Austin Health - Melbourne
Recruitment hospital [2] 0 0
Royal Melbourne Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
- Melbourne

Funding & Sponsors
Primary sponsor type
Government body
Name
Austin Health
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Royal Melbourne Hospital, Australia
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06916819