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

ConditionFood Allergies

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorAustin Health

About this trial

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 criteria

Qualifiers

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

Aged greater than 18 years

Disqualifiers

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

Trial design

Treatments tested in this trial

Home-Based Food Challenge
In-Clinic Food Challenge

Treatment groups

120 Participants

are divided into 2 treatment groups

Sponsors and collaborators

Austin Health

Lead sponsor

Royal Melbourne Hospital, Australia

Collaborator

Source ClinicalTrials.gov