An interventional study of cashew oral immunotherapy in Food Allergy in Children, sponsored by Murdoch Childrens Research Institute. Not yet recruiting. Open to participants aged 1 Year to 5 Years. Per ClinicalTrials.gov, last updated 2026-10-09.
Sponsored by Murdoch Childrens Research Institute · Not applicable, Interventional, and Treatment
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.
This is a prospective, single-arm, open-label pilot clinical trial evaluating a remission-focused rapid escalation, high-dose oral immunotherapy (OIT) protocol designed to induce clinical remission in children aged 1-5 years with challenge-confirmed cashew allergy.
Trial population: 25 participants ages 1-5 years with current cashew allergy confirmed by a failed cashew oral food challenge (OFC) and a positive cashew SPT or sIgE level at screening.
Study duration per participant \~ 17 months. Participants will receive cashew OIT daily for 12 months. Study phases include: Initial treatment day, build-up phase, maintenance (until 12 months of treatment is completed) and then elimination phase (OFC will be performed after treatment completion and 8 weeks after end-of-treatment).
345 studies on the registry are indexed under Food Hypersensitivity; 87 are open to participants now.
This study's planned enrollment of 25 is below the median of 60 across 215 interventional studies indexed under Food Hypersensitivity.
Browse Food Hypersensitivity studies →Murdoch Childrens Research Institute is the lead sponsor of 98 studies on the registry; 33 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
open label pilot study
Other: cashew oral immunotherapy
Enrolled 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.
Time frame: Day 1
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.
Time frame: Day 1
Proportion of participants who complete the Build-Up schedule according to the protocol
72% is defined as successful.
Time frame: Week 2 through to Week 16
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
Time frame: Day1 through to Month 14
Proportion of participants with a treatment-related unexpected serious adverse event
This outcome will allow assessment of the safety of the intervention
Time frame: Day 1 through to Month 12
Proportion of participants who discontinue due to adverse events
This will allow assessment of the safety of the intervention
Time frame: Day 1 through to Month 12
No study locations are listed for this record.
Plan to share: Yes — The de-identified data set collected for this analysis of the REACH Trial will be available beginning 24 months after publication of the primary outcome, subject to completion of any intellectual property protection steps. The study protocol and analysis plan will also be available.
Supporting information: Study protocol, Statistical analysis plan
Time frame: Beginning 24 months after publication of the primary outcome.
Access criteria: Access: The data must be obtained from the Murdoch Children's Research Institute. Prior to release, the following are required: a signed data access/transfer agreement between the relevant parties; review and approval of the proposed analysis plan by the Study Management Group; agreement on appropriate acknowledgment; and coverage of any additional costs. The data access agreement will address intellectual property, including that no rights in the study's background intellectual property (IP) are transferred and how any results or inventions arising from use of the data are treated. Data will only be shared with a recognised research organisation that has agreed to these terms and whose analysis plan has been approved. Where the Study Management Group is unavailable, this role is delegated to the Murdoch Children's Research Institute.
Data sharing details ↗ · www.mcri.edu.au
No publications or documents are linked to this record.
Start is estimated for Oct 2026; primary completion for Oct 2028, 24 months later.
Of 83 non-industry interventional studies with no phase under Food Hypersensitivity, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 50. This study's planned 24 months is below that.
Counting every sponsor, half of 86 studies reached it within 26 months; a quarter within 13 and three quarters within 44.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Murdoch Childrens Research Institute