The TreEat Study- Can Early Introduction of Tree Nuts Prevent Tree Nut Allergy in Infants With Pe… (NCT04801823) | Clinical Trial Compass
CompletedPhase 3
The TreEat Study- Can Early Introduction of Tree Nuts Prevent Tree Nut Allergy in Infants With Peanut Allergy
Australia212 participantsStarted 2021-06-01
Plain-language 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.
Who can participate
Age range
4 Months – 11 Months
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since my infant already has a peanut allergy, is early introduction of tree nuts something my doctor would consider as a strategy to potentially prevent tree nut allergy, based on what this TreEat study found?
2This was a Phase 3 trial that has already completed — has my doctor seen or reviewed any published results from TreEat showing whether early tree nut introduction made a meaningful difference in allergy rates by 18 months of age?
3The study tracked outcomes until 18 months old — given my child's current age, is that window for early introduction still open, or have we already passed the point where this approach might be relevant?
4Since this trial specifically involved infants with peanut allergy, how does my child's current allergy profile and any prior reactions affect whether early tree nut introduction would be considered safe to try under medical supervision?
5Would my doctor recommend waiting for standard allergy specialist guidance on this topic, or does the evidence from a completed Phase 3 trial like this already inform how they approach tree nut introduction in peanut-allergic infants?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Difference between the two treatment arms in the proportion of participants with clinical confirmed tree nut allergy at 18 months of age