Status:
RECRUITING
Food Challenge at Home or in Medical Practice - the FoodCHOMP Study
Lead Sponsor:
Austin Health
Collaborating Sponsors:
Royal Melbourne Hospital, Australia
Conditions:
Food Allergies
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 ar...
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 ch...
Eligibility Criteria
Inclusion
- Negative (\<3mm) fresh or extract skin testing to the food implicated within their allergy label
- Aged greater than 18 years
Exclusion
- 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
Key Trial Info
Start Date :
April 16 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06916819
Start Date
April 16 2025
End Date
December 1 2026
Last Update
April 17 2025
Active Locations (2)
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1
Austin Health
Melbourne, Victoria, Australia
2
Royal Melbourne Hospital
Melbourne, Victoria, Australia