Children with cashew allergy have no approved treatment and must rely on lifelong avoidance, which is stressful and often fails. Less than 10% outgrow their allergy. Cashew is a leading cause of severe reactions in young children. Oral immunotherapy (OIT) can induce remission in peanut allergy, allowing children to eat peanut safely, but this has not been tested for cashew. This study will assess whether cashew OIT can safely achieve remission and improve quality of life.
Age between 1 year and 5 years
>7kg (the weight considered safe for the administration of an adrenaline device)
Cashew allergy confirmed by failed cashew oral food challenge (OFC) AND positive cashew skin prick test (SPT) or specific Immunoglobulin E (sIgE) at screening
Has a legal representative capable of understanding the informed consent document and providing consent on the participant's behalf
History of severe anaphylaxis to cashew (as defined by persistent hypotension, collapse, loss of consciousness, persistent hypoxia or ever needing more than three (3) doses of intramuscular adrenaline or an intravenous adrenaline infusion for management of an allergic reaction)
Severe anaphylaxis during the study entry challenge (defined as persistent hypotension, collapse, loss of consciousness, persistent hypoxia, or requiring more than 3 doses of intramuscular adrenaline or an intravenous adrenaline infusion for management of an allergic reaction)
Ongoing chronic persistent asthma (as per Australian Asthma Foundation guidelines)
Underlying medical conditions (e.g. cardiac disease) that increase the risks associated with anaphylaxis
Single group
cashew oral immunotherapy
Other interventionEnrolled participants will receive cashew immunotherapy daily for 12 months
Proportion of consented participants who are eligible for the Ultra-Rush Day
72% is defined as successful. This outcome will determine the feasibility of recruitment.
Proportion of participants who complete the Ultra-Rush Day schedule according to the protocol
72% is defined as successful. This outcome will determine the feasibility of the protocol.
Proportion of participants who complete the Build-Up schedule according to the protocol
72% is defined as successful.
Proportion of participants who complete the Ultra-Rush Day (Day 1) to the post-treatment visit done 8 weeks after ceasing treatment
72% is defined as successful
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This trial is not recruiting at the moment. You can still explore other options:
