The TreEat Study- Can Early Introduction of Tree Nuts Prevent Tree Nut Allergy in Infants with Peanut Allergy

Murdoch Childrens Research Institute

Status and phase: Active, not recruiting; Phase 3

Conditions: Food Allergy in Infants; Nut Allergy

Treatments: Other: Home introduction; Other: Multi Nut oral food challenge

Study type: Interventional

Funder types: Other

Identifiers

NCT04801823

70489

Details and patient eligibility

About

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.

Enrollment: 212 patients

Sex: All

Ages: 4 to 11 months old

Volunteers: No Healthy Volunteers

Inclusion criteria

Infants aged greater than 4 months and less than 11 months of age diagnosed with IgE-mediated peanut allergy in conjunction with a positive SPT (≥3mm) or sIgE (specific immunoglobulin E) (>0.35 kU/L)

Exclusion criteria

• Any history of severe food induced anaphylaxis. Defined as reaction requiring 2 doses of intramuscular (IM) adrenaline.
• Pre-existing tree nut allergy (parent-reported).
• Any tree nut already tolerated (ingestion on >3 occasions without reaction of around 1 teaspoon)
• SPT or sIgE performed to any tree nuts
• Not commenced or unable to eat solid food
• Prescribed beta-blocker medication

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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212 participants in 2 patient groups

Home Introduction of Individual tree nuts

Active Comparator group

Description:

Current standard of care which is to advise families of infants diagnosed with peanut allergy to introduce tree nuts individually via a standardized, graded and cautious home introduction protocol. Day 1: smear of nut paste to the inside of lip; Day 2: 1/8 teaspoon; Day 3: 1/4 teaspoon; Day 4: 1/2 teaspoon; Day 5: 1 teaspoon. Repeat process with each individual tree nut.

Treatment:

Other: Home introduction

In hospital multi-tree nut (almond, cashew hazelnut and walnut) oral food challenge (OFC)

Experimental group

Description:

Infant will be booked for a 4-nut butter (Almond, Hazelnut, Walnut, and Cashew) graded and supervised OFC in the allergy clinical trials unit at the Murdoch Children's Research Institute. The nut butter contains a 1g dose of each nut protein in a total weight of 20g. Doses will be administered every 15minutes (1. Smear to inside of lip, 2.1/8 teaspoon, 3.1/4 teaspoon, 4.1/2 teaspoon, 5.1 teaspoon, 6.remainder of 20g nut butter paste) If challenge negative, infants continue home introduction of tree nuts as per written instructions provided. If challenge positive, infants will have additional SPT (for full tree nut panel) and single tree nut OFC as per protocol to determine tolerance/allergic status (and +/- home introduction recommendation) for each tree nut.

Treatment:

Other: Multi Nut oral food challenge