Randomized Study of Home-Based Versus In-Clinic Oral Food Challenges in Adults with Low-Risk Food Allergies

What this Trial Is About

Food allergies are common and can cause anxiety and heavy use of healthcare resources. Many adults carry food allergy labels without confirmed diagnosis through food challenges, often leading to unnecessary avoidance. This study is a pilot, multi-center, randomized clinical trial aiming to evaluate the safety and feasibility of conducting oral food challenges at home for adults with low-risk food allergy labels confirmed by negative skin prick tests. Participants will be randomly assigned to either a home-based or standard in-clinic oral food challenge. The home-based challenge lasts five days, starting with a supervised dose in a clinic followed by incremental doses at home with daily phone follow-up. The in-clinic challenge involves increasing doses given every 20-30 minutes over 2-3 hours with medical supervision and observation afterward. Both groups select the food to be challenged from their allergy labels. During the study, participants will be monitored for immune-mediated adverse events, protocol adherence, quality of life changes, and food reintroduction outcomes. Data on recruitment feasibility and safety will also be collected. The trial includes clinical assessments, skin prick testing, and daily follow-up for the home challenge group. The total participation period spans the challenge days and includes a 6-month follow-up to assess quality of life and food consumption.

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