Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06916819

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

Led by Austin Health · Updated on 2025-04-17

120

Participants Needed

2

Research Sites

84 weeks

Total Duration

On this page

Sponsors

A

Austin Health

Lead Sponsor

R

Royal Melbourne Hospital, Australia

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Negative (less than 3mm) skin test to the food involved in your allergy label
  • Aged over 18 years
Not Eligible

You will not qualify if you...

  • Evidence of prior sensitisation to the challenge food such as previous positive skin test or specific IgEs
  • Pregnancy
  • Poorly controlled asthma defined by ACQ5 score greater than 1 at enrolment
  • History of food reactions not consistent with IgE allergy, such as only gastrointestinal symptoms or FPIES
  • History of food-dependent exercise induced anaphylaxis
  • Use of medications that may affect challenge outcome including antihistamines, high dose steroids (over 50mg QID hydrocortisone or equivalent), or Omalizumab
  • Any other illness that increases risk for participation as judged by the investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

Austin Health

Melbourne, Victoria, Australia

Actively Recruiting

2

Royal Melbourne Hospital

Melbourne, Victoria, Australia

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

DIAGNOSTIC

Number of Arms

2

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