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NOT YET RECRUITING

NCT07868731

Rapid Escalation Oral Immunotherapy to Achieve Remission in Children With Cashew Allergy

Sponsor: Murdoch Childrens Research Institute

View on ClinicalTrials.gov

Summary

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.

Official title: REACH-Cashew: Rapid Escalation Oral Immunotherapy to Achieve Remission in Children With Cashew

Key Details

Gender

All

Age Range

1 Year - 5 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2027-05

Completion Date

2030-05

Last Updated

2026-11-03

Healthy Volunteers

Conditions

Food Allergy in Children

Interventions

OTHER

cashew oral immunotherapy

Enrolled participants will receive cashew immunotherapy daily for 12 months

Inclusion Criteria: * 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 Exclusion Criteria: * 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 * History of suspected or biopsy-confirmed eosinophilic oesophagitis (EoE) * Current use of beta-blockers or angiotensin-converting enzyme (ACE) inhibitors, cardiovascular disease or ongoing chronic persistent asthma that increase the risks associated with anaphylaxis * Have received other food immunotherapy treatment in the preceding 12 months or currently taking immunomodulatory therapy (including allergen immunotherapy) * Currently taking immunomodulatory therapy (including allergen immunotherapy) * Past or current major illness that in the opinion of the Principal Investigator may affect the participant's ability to participate in the study e.g. increased risk to the participant * Participants who in the opinion of the Principal Investigator are unable to follow the protocol * Another family member already enrolled in the trial (to maintain safety and equity of access)