Can early introduction of tree nuts prevent tree nut allergy? TreEat: a randomized controlled trial
BACKGROUND: Allergies to tree nuts, such as almond, cashew, hazelnut and walnut can be severe, are often lifelong and seem to be increasing in some parts of the world. GAP: It is known that introduction of peanut and egg in the first year of life is protective for the development of peanut and egg allergies however it is not known if this applies to other allergens, including tree nuts. To facilitate timely introduction, it is common practice in Australia for families of infants with peanut allergy to be advised to introduce all tree nuts at home without prior allergy testing (screening). The safety and effectiveness of this home-based model has not been formally evaluated. HYPOTHESIS: We hypothesize that in high-risk infants (those with established peanut allergy), a hospital-based multi-tree nut oral food challenge (OFC) compared to the standard care of home-based individual tree nut introduction will: a. reduce rates of tree nut allergy b. support the safe and timely introduction of tree nuts into the diet c. improve parental quality of life and anxiety d. reduce health care costs METHODS: The TreEat trial is a 2-armed, open-label, randomized, controlled trial to assess the safety and efficacy of a supervised hospital-based multi-tree nut (almond, cashew, hazelnut, and walnut) OFC versus standard care in infants with peanut allergy to reduce tree nut allergy. RESULTS: Pending IMPACT: Within the next 4 years, this trial will provide evidence for direct translation into clinical practice for the prevention of tree nut allergy in high-risk infants.