CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 212 enrolled
Drug / intervention
Home introduction +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04801823
NCT04801823Phase 3Completed

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

Murdoch Childrens Research Institute·interventional·Posted Mar 17, 2021·Updated Feb 19, 2026

In Brief

A Phase 3 clinical trial evaluating Home introduction and Multi Nut oral food challenge for Food Allergy in Infants and Nut Allergy. Completed, enrolled 212 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustralia
Collaborators--

Timeline

Phase 3CompletedFinished
20222023202420252026
First PostedMar 17, 2021
Enrollment StartJun 1, 2021
Primary CompletionJun 29, 2025
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 5.3 years ago

Interventions

Home introductionother

Cautious, graded introduction of individual tree nuts

Multi Nut oral food challengeother

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