Home-based food challenges for adults with food allergies
Food Challenge at Home or in Medical Practice - a Multi-center Randomized Control Trial - FoodCHOMP Study
This study is testing if it's safe and practical for adults with certain food allergies to try eating those foods at home instead of in a clinic.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Austin Health Government |
| Drugs / interventions | Omalizumab |
| Locations | 2 sites (Melbourne, Victoria and 1 other locations) |
| Trial ID | NCT06916819 on ClinicalTrials.gov |
What this trial studies
This pilot, multi-centre, randomised clinical trial evaluates the safety and feasibility of conducting oral food challenges at home for adults with low-risk food allergy labels. Participants aged 18 and older, who have negative skin prick tests to the implicated food, will be randomly assigned to either a home-based challenge or a standard in-clinic challenge. The study aims to assess the safety of home challenges by monitoring immune-mediated adverse events, while also evaluating recruitment feasibility, protocol adherence, quality of life, and food reintroduction outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with self-reported food allergies and negative skin prick tests to the implicated food.
Not a fit: Patients with a history of severe allergic reactions or those with poorly controlled asthma may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could reduce unnecessary food avoidance and anxiety for patients with food allergies by confirming food tolerance in a more accessible setting.
How similar studies have performed: While in-clinic food challenges are standard, this home-based approach is novel and has not been extensively tested in similar studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Negative (\<3mm) fresh or extract skin testing to the food implicated within their allergy label 2. Aged greater than 18 years 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
Where this trial is running
Melbourne, Victoria and 1 other locations
- Austin Health — Melbourne, Victoria, Australia (Recruiting)
- Royal Melbourne Hospital — Melbourne, Victoria, Australia (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.