Home-based food challenges for adults with food allergies

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Austin Health
  Melbourne, Victoria, Australia Recruiting
• Royal Melbourne Hospital
  Melbourne, Victoria, Australia Recruiting

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.