A Phase 3 interventional study of Home introduction and Multi Nut oral food challenge in Food Allergy in Infants and Nut Allergy, sponsored by Murdoch Childrens Research Institute. Completed at 1 site in Australia. Open to participants aged 4 Months to 11 Months. Per ClinicalTrials.gov, last updated 2026-02-19.
Sponsored by Murdoch Childrens Research Institute · Phase 3, Interventional, and Prevention
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.
33 studies on the registry are indexed under Nut Hypersensitivity; 9 are open to participants now.
This study's enrollment of 212 is above the median of 47 across 20 interventional studies indexed under Nut Hypersensitivity.
Browse Nut Hypersensitivity studies →Murdoch Childrens Research Institute is the lead sponsor of 99 studies on the registry; 34 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.
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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:
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.
Other: Home introduction
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.
Other: Multi Nut oral food challenge
Cautious, graded introduction of individual tree nuts
In hospital multi nut oral food challenge (almond, cashew, hazelnut, walnut)
Difference between the two treatment arms in the proportion of participants with clinical confirmed tree nut allergy at 18 months of age
Tree nut allergy outcomes at 18 months will be defined as: 1. 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 2. 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. 3. Inconclusive -has an unknown outcome as ingestion has not occurred and participant declines OFC.
Time frame: 18 months of age
Difference between the two treatment arms in the proportion of participants with ongoing peanut allergy at 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
Time frame: 18 months of age
Difference between the two treatment arms in the proportion and severity of reported adverse events (AE) related to tree nut ingestion.
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.
Time frame: 18 months of age
Difference between the two treatment arms in the proportion and severity of solicited AEs related to tree nut ingestion.
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.
Time frame: 18 months of age
Difference between the 2 treatment arms in the number of tree nuts ingested.
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.
Time frame: 18 months of age
Difference between the 2 treatment arms in the frequency of tree nuts ingested.
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.
Time frame: 18 months of age
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.
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
Time frame: Baseline and 18 months of age
Difference between the two treatment arms in the mean change from baseline in State/Trait anxiety scores using the State/Trait Anxiety Inventory
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.
Time frame: Baseline and 18 months of age
Difference in the number of allergy-related healthcare visits from randomization to 18 months of age between the treatment arms
Captured per number of hospitalizations, Emergency room (ER) visits, physician office visits, and medications / number of prescriptions from randomization to 18 months of age.
Time frame: 18 months of age
Plan to share: Yes — The de-identified data set collected for this analysis of the TreEat trial will be available six months after publication of the primary outcome. The study protocol may be obtained from the Murdoch Children's Research Institute. Prior to releasing any data the following are required: a data access agreement must be signed between relevant parties, the TreEat trial investigators must see and approve the analysis plan describing how the data will be analyzed, there must be an agreement around appropriate acknowledgment and any additional costs involved must be covered. Should the study investigators be unavailable, this role is delegated to the Murdoch Children's Research Institute. Data will only be shared with a recognized research institute which has approved the proposed analysis plan.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: 6 months after publication of primary outcome
Access criteria: Prior to releasing any data the following are required: a data access agreement must be signed between relevant parties, the TreEat trial investigators must see and approve the analysis plan describing how the data will be analyzed, there must be an agreement around appropriate acknowledgment and any additional costs involved must be covered.
Ran from Jun 2021 to primary completion in Jun 2025, 48 months.
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