The TreEat Study- Can Early Introduction of Tree Nuts Prevent Tree Nut Allergy in Infants With Peanut Allergy (TreEat)
The TreEat Study- Can Early Introduction of Tree Nuts Prevent Tree Nut Allergy in Infants With Peanut Allergy (TreEat)
Early and regular ingestion of the common allergens, peanut and egg has been shown to be an effective allergy prevention strategy. It is not clear whether this is also true of tree nut allergy. Current practice in many Australian allergy clinics for children with peanut allergy (high risk of tree nut allergy), is to advise families to introduce each individual tree nut into their child's diet via a cautious home introduction protocol without prior allergy testing (screening). The safety and effectiveness of an early and regular ingestion strategy for the prevention of tree nut allergy has not been formally evaluated and it is known that around a third of children with peanut allergy develop one or more other nut allergies. This trial is a 2-armed, open-label, randomized, controlled trial (RCT) to assess the safety and efficacy of a supervised hospital based multi-tree nut (almond, cashew, hazelnut and walnut) oral food challenge (OFC) + then home introduction of the remaining tree nuts versus standard care (home introduction of all 8 tree nuts) in infants with peanut allergy to reduce the risk of developing tree nut allergy.
Study Type: Interventional (Clinical Trial)
Estimated Enrollment: 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Can Early Introduction of Tree Nuts Prevent Tree Nut Allergy in Infants at High Risk of Tree Nut Allergy: The TreEat Study: a Randomised, Open-label Controlled Trial
Estimated Study Start Date: April 1, 2021
Estimated Primary Completion Date: November 1, 2023
Estimated Study Completion Date: May 1, 2024
Arm:
- Active Comparator: Home Introduction of Individual tree nuts
- Experimental: In hospital multi-tree nut (almond, cashew hazelnut and walnut) oral food challenge (OFC)
| Category | Value |
|---|---|
| Study type(s) | Interventional |
| Estimated enrolment | 200 |
| Estimated Study start date | 01 April 2021 |
| Estimated Study Completion Date | 01 May 2024 |