Clinical trial NCT04801823: The TreEat Study- Can Early Introduction of Tree Nuts Prevent Tree Nut Allergy in Infants with Peanut Allergy
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Food Allergy in Infants
Nut Allergy
Keywords: food allergy
nut allergy
Lead sponsor: Murdoch Childrens Research Institute
Sponsor class: OTHER
First posted: 2021-03-17
Enrollment: 212
Sex: ALL
Minimum age (years): 4
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Difference between the two treatment arms in the proportion of participants with clinical confirmed tree nut allergy at 18 months of age
timeFrame: 18 months of age
Secondary outcomes:
measure: Difference between the two treatment arms in the proportion of participants with ongoing peanut allergy at 18 months of age
timeFrame: 18 months of age
measure: Difference between the two treatment arms in the proportion and severity of reported adverse events (AE) related to tree nut ingestion.
timeFrame: 18 months of age
measure: Difference between the two treatment arms in the proportion and severity of solicited AEs related to tree nut ingestion.
timeFrame: 18 months of age
measure: Difference between the 2 treatment arms in the number of tree nuts ingested.
timeFrame: 18 months of age
measure: Difference between the 2 treatment arms in the frequency of tree nuts ingested.
timeFrame: 18 months of age
measure: Difference between the two treatment arms in mean change from baseline of Quality of Life Scores using the Food Allergy Quality of Life Questionnaire (FAQLQ-PF)- Parent Form at 18 months of age.
timeFrame: Baseline and 18 months of age
measure: Difference between the two treatment arms in the mean change from baseline in State/Trait anxiety scores using the State/Trait Anxiety Inventory
timeFrame: Baseline and 18 months of age
measure: Difference in the number of allergy-related healthcare visits from randomization to 18 months of age between the treatment arms
timeFrame: 18 months of age
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Murdoch Children's Research Institute (MCRI)
state: Victoria
Study officials:
affiliation: Murdoch Childrens Research Institute
name: Kirsten Perrett, MD. PhD
role: PRINCIPAL_INVESTIGATOR
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