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Completed

NCT Number: NCT04801823

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

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.

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Key information

Conditions

Food Allergy in Infants Food Hypersensitivity Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Nut Allergy Nut Hypersensitivity Nut and Peanut Hypersensitivity

Age range

4 month–11 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Murdoch Children's Research Institute (MCRI)

Melbourne, Victoria, 3052, Australia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Home introduction

Other

Cautious, graded introduction of individual tree nuts

Multi Nut oral food challenge

Other

In hospital multi nut oral food challenge (almond, cashew, hazelnut, walnut)

Primary outcomes

  1. Difference between the two treatment arms in the proportion of participants with clinical confirmed tree nut allergy at 18 months of age

    Time frame: 18 months of age

    Tree nut allergy outcomes at 18 months will be defined as:

    • Allergic - has evidence of tree nut sensitization (SPT>=3mm) and has had a reaction consistent with IgE (immunoglobulin E) mediated food allergy OR positive formal OFC
    • Tree nut tolerant- successfully tolerated the tree nut at home on more than 3 occasions of at least 1 teaspoon of nut per occasion OR has had a negative formal OFC.
    • Inconclusive -has an unknown outcome as ingestion has not occurred and participant declines OFC.

Secondary outcomes

  1. Difference between the two treatment arms in the proportion of participants with ongoing peanut allergy at 18 months of age

    Time frame: 18 months of age

    Peanut allergy will be defined as peanut sensitization (SPT >=3mm) AND has had a reaction consistent with IgE mediated food allergy since randomization OR positive formal OFC

  2. Difference between the two treatment arms in the proportion and severity of reported adverse events (AE) related to tree nut ingestion.

    Time frame: 18 months of age

    Number and severity of adverse events (AE) as assessed by standardised predetermined criteria, related to tree nut ingestion from randomization to 18 months of age collected via parent questionnaire and medical history.

  3. Difference between the two treatment arms in the proportion and severity of solicited AEs related to tree nut ingestion.

    Time frame: 18 months of age

    Number and severity of solicited AEs as assessed by standardized predetermined criteria, related to tree nut ingestion from randomization to 18 months of age collected via parent questionnaire and medical history.

  4. Difference between the 2 treatment arms in the number of tree nuts ingested.

    Time frame: 18 months of age

    Parent reported tree nut ingestion history based on questionnaire at baseline and 18 months of age. 0-8 tree nuts and the higher the number of tree nuts the better.

  5. Difference between the 2 treatment arms in the frequency of tree nuts ingested.

    Time frame: 18 months of age

    Parent reported tree nut ingestion history based on questionnaire at baseline and 18 months of age. Range will be never to daily with higher frequency better.

  6. 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.

    Time frame: Baseline and 18 months of age

    The Food Allergy Quality of Life Questionnaires (FAQLQ) are disease-specific health-related quality of life (HRQL) questionnaires for patients with food allergy. FAQLQ-PF (Parent Form), completed by parents of children aged 0-12 years consists of 30 items over 3 domains (emotional impact, food anxiety, social and dietary restrictions). Total and domain scores are calculated by dividing the sum of completed items by the number of completed items. Questions are based on a 6 point Likert scale with higher scores indicating greater impact on quality of life

  7. Difference between the two treatment arms in the mean change from baseline in State/Trait anxiety scores using the State/Trait Anxiety Inventory

    Time frame: Baseline and 18 months of age

    The State-Trait Anxiety Inventory (STAI) is a psychological inventory based on a 4-point Likert scale and consists of 40 questions on a self-report basis. The STAI measures two types of anxiety - state anxiety, or anxiety about an event, and trait anxiety, or anxiety level as a personal characteristic. The total score ranges from 0-63 with higher scores positively correlated with higher levels of anxiety.

  8. Difference in the number of allergy-related healthcare visits from randomization to 18 months of age between the treatment arms

    Time frame: 18 months of age

    Captured per number of hospitalizations, Emergency room (ER) visits, physician office visits, and medications / number of prescriptions from randomization to 18 months of age.

Sponsors and collaborators

Lead sponsor

Murdoch Childrens Research Institute

Other

Registry information

Official study 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

Acronym: TreEat

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Mar 17, 2021
Registry last updated
Feb 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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