*Closed Recruitment*

Study short name: The TreEat Pilot Study

Study full name: Is early introduction of tree nuts in infants at high risk of food allergy feasible? The TreEat Pilot Study: A randomised, open-label controlled trial

Principle Investigator: Kirsten Perrett

Administering Institute: Murdoch Children’s Research Institute

Major funding sources: Murdoch Children’s Research and the Australian Food Allergy Foundation

Study focus: Prevention

Study design: Intervention

Main study aim: To find out if the introduction of multiple tree nuts in a hospital oral food challenge is better for prevention of tree nut allergy and is easier for families, than standard care (home based introduction of individual tree nuts).

Additional study information: Early and regular ingestion of the common allergens, peanut, and egg, has been shown to be an effective allergy prevention strategy. Little is known about tree nut allergy. Current allergy testing methods are indicative of IgE sensitisation only and are not diagnostic of food allergy. Current practice at The Royal Children’s Hospital (RCH) allergy clinic in children who are egg and/or peanut allergic 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 this strategy has not been formally evaluated.

This pilot study is a 2-armed, open-label, randomised, controlled trial (RCT)  to assess the safety and feasibility of a supervised hospital based multi-tree nut oral food challenge (OFC) versus standard care (home introduction of individual tree nuts) in  infants with egg and/or peanut allergy to reduce the risk of developing tree nut allergy.

This proof of concept study will test the integrity of the study protocol, case report forms, multi-nut OFC approach and laboratory and diagnostic methods for the future definitive trial.

Study population: Infants aged >4 months and less than 11 months of age referred to the Department of Allergy at The Royal Children’s Hospital (RCH) with a history of an IgE-mediated allergic reaction to egg and/or peanut who are not yet consuming tree nuts.

Study status: Recruitment ongoing*, through Dec 2020.

*Participants are recruited from the Royal Children’s Hospital (RCH) Allergy Department waiting list.

This study is unable to accept volunteers.

Where can I find more information?

Australia New Zealand Clinical Trials Registry:  https://www.australianclinicaltrials.gov.au/anzctr/trial/ACTRN12619000897167p

Study contact:  [email protected]

Last modified: July 28th 2020