Food AllergiesCHOMPNCT06916819
Food Challenge at Home or in Medical Practice - the FoodCHOMP Study
A study testing Home-Based Food Challenge and In-Clinic Food Challenge in people with Food Allergies, run by Austin Health at 2 sites in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Food Allergies
- What is being tested?
- Home-Based Food Challenge and In-Clinic Food Challenge
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesAustralia
- Study dates
- 16 Apr 2025to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Negative (<3mm) fresh or extract skin testing to the food implicated within their allergy label
- Aged greater than 18 years
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Australia2 sites, 2 recruiting
- Recruiting
Austin Health
Melbourne, Victoria
Jack Godsell, +613 9496 5000, immunology@austin.org.au
Jack Godsell
- Recruiting
Royal Melbourne Hospital
Melbourne, Victoria
Jack Godsell, 61393427191, allergyresearch@mh.org.au
About this study
Official title: Food Challenge at Home or in Medical Practice - a Multi-center Randomized Control Trial - FoodCHOMP Study
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.
Read the 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.
- Conditions
- Food Allergies
- Being tested
- Home-Based Food Challenge, In-Clinic Food Challenge
- Keywords
- Food allergy, Food allergy label, Food Challenge
- Medical subject headings
- Food Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home-Based Food ChallengeDiagnostic 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.
In-Clinic Food ChallengeDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Diagnostic Test: Home-Based Food Challenge |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Feasibility metric defined as the proportion of patients referred to outpatient allergy clinic who meet the trial eligibility criteria (including negative skin prick testing to the implicated food and absence of exclusion criteria).
Measured: Baseline visit
Proportion of eligible patients who consent to participate (Recruitment-to-eligibility ratio)
Feasibility of recruitment measured as the proportion of eligible patients who provide written informed consent to participate in the trial.
Measured: At consent discussion (baseline visit)
Proportion of randomised participants who receive the allocated intervention (Intervention-to-recruitment ratio)
Defined as the proportion of randomised participants who complete their allocated food challenge (home or in-clinic) in accordance with protocol.
Measured: Day 1 to Day 5 (intervention delivery period)
Proportion of participants experiencing non-immune mediated adverse events
Non-immune mediated events include those not consistent with IgE-mediated allergy and not meeting serious adverse event criteria. Examples: taste aversion, food refusal, procedural anxiety. Events will be recorded via self-report or in-clinic observation.
Measured: Day 1 to Day 5 (challenge period)
Proportion of participants with severe adverse reactions (anaphylaxis or death)
Serious adverse events are defined per ICH-GCP and include anaphylaxis (as per ASCIA criteria) or death.
Measured: Day 1 to Day 5 (challenge period)
Difference in proportion of participants tolerant to challenge food
Defined as the proportion of participants in each arm who successfully consume the full challenge dose without meeting stopping criteria or experiencing adverse events. Tolerance is determined according to protocol-defined thresholds.
Measured: At completion of challenge (Day 5)
Change in Food Allergy Quality of Life (FAQLQ-12) score from baseline
Measured using the FAQLQ-12, a validated 12-item quality of life tool for adults with food allergy. Change in score will be assessed as a continuous variable.
Measured: Baseline and 6 months post-randomisation
Proportion of participants consuming the challenge food post-trial
Defined as the proportion of participants who report active inclusion of the challenge food in their diet at least once per week following a successful challenge.
Measured: At 6-month follow-up
Time from clinic referral to challenge completion
Measured in days to assess whether home-based challenge reduces diagnostic delay compared to in-clinic challenge.
Data collected through clinic administrative records.
Measured: From the date of referral for food challenge to date of challenge completion or withdrawal from the study assessed up to 60 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2025
- Study start16 Apr 2025
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Food AllergiesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Austin Health
- Sponsor type
- Other government
- Collaborators
- Royal Melbourne Hospital, Australia
- Responsible party
- Principal investigator, Jack Godsell, Austin Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06916819
- Sponsor's protocol ID
- 111750/Austin-2024
- Acronym
- CHOMP
- Status last verified
- Apr 2025
- First submitted
- 26 Mar 2025
- Last updated
- 17 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share IPD with other researchers
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.
PubMed 41651530
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Food Challenge at Home or in Medical Practice - a Multi-center Randomized Control Trial - FoodCHOMP Study
- ClinicalTrials.gov ID
- NCT06916819
- Acronym / sponsor ID
- CHOMP / 111750/Austin-2024
- Conditions
- Food Allergies
- Keywords
- Food allergy, Food allergy label, Food Challenge
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Austin HealthOther government
- Collaborators
- Royal Melbourne Hospital, Australia
- Study start
- 16 Apr 2025 (actual)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 8 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| In-Clinic Food Challenge (Control Arm) | Other | Diagnostic Test: In-Clinic Food ChallengeParticipants 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. |
| Home-Based Food Challenge (Intervention Arm) | Experimental | Diagnostic Test: Home-Based Food ChallengeParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Negative (<3mm) fresh or extract skin testing to the food implicated within their allergy label
- Aged greater than 18 years
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home-Based Food ChallengeParticipants 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 (Intervention Arm) |
| In-Clinic Food ChallengeStandard 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. | Diagnostic test | In-Clinic Food Challenge (Control Arm) |
Primary outcome
Proportion of participants experiencing immune-mediated adverse events during food challenge
Time frame: During the food challenge period (Days 1-5 post-randomisation)
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.
9 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2025.
- Derived from this study: PubMed 41651530Godsell 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.
- Individual participant dataSharing planned: No. There is no plan to share IPD with other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home-Based Food Challenge and In-Clinic Food Challenge in people with Food Allergies, run by Austin Health at 2 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants experiencing immune-mediated adverse events during food challenge (time frame: During the food challenge period (Days 1-5 post-randomisation)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06916819, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2025.