Food Allergy in ChildrenREACH-CashewNCT07868731
Rapid Escalation Oral Immunotherapy to Achieve Remission in Children With Cashew Allergy
A study testing cashew oral immunotherapy in people with Food Allergy in Children, run by Murdoch Childrens Research Institute.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 5 years
- Conditions the study is for
- Food Allergy in Children
- What is being tested?
- cashew oral immunotherapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- May 2027to May 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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)
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Amanda Burgess contact
About this study
Official title: REACH-Cashew: Rapid Escalation Oral Immunotherapy to Achieve Remission in Children With Cashew
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.
Read the detailed description
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).
- Conditions
- Food Allergy in Children
- Being tested
- cashew oral immunotherapy
- Keywords
- oral immunotherapy, food allergy, paediatrics
- Medical subject headings
- Food Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cashew oral immunotherapyOther
Enrolled participants will receive cashew immunotherapy daily for 12 months
| Study group | Role | What they receive |
|---|---|---|
| cashew oral immunotherapy | Other | open label pilot study Receives: Other: cashew oral immunotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Day 1
Proportion of participants who complete the Build-Up schedule according to the protocol
72% is defined as successful.
Measured: 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
Measured: 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
Measured: 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
Measured: Day 1 through to Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2026
- Study startMay 2027 (estimated)
- Primary completionMay 2029 (estimated)
- Study completionMay 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Food Allergy in ChildrenStudies of the same condition, open and under way.
- More trials run by Murdoch Childrens Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Murdoch Childrens Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mimi Tang, Prof, Principal investigator, Murdoch Childrens Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07868731
- Sponsor's protocol ID
- 129383
- Acronym
- REACH-Cashew
- Status last verified
- Nov 2026
- First submitted
- 5 Oct 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REACH-Cashew: Rapid Escalation Oral Immunotherapy to Achieve Remission in Children With Cashew
- ClinicalTrials.gov ID
- NCT07868731
- Acronym / sponsor ID
- REACH-Cashew / 129383
- Conditions
- Food Allergy in Children
- Keywords
- oral immunotherapy, food allergy, paediatrics
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Murdoch Childrens Research InstituteUniversity, hospital or other
- Study start
- May 2027 (estimated)
- Primary completion
- May 2029 (estimated)
- Study completion
- May 2030 (estimated)
- First posted
- 9 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cashew oral immunotherapy | Other | Other: cashew oral immunotherapyopen label pilot study |
Who may qualify
- Ages
- 1 year to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cashew oral immunotherapyEnrolled participants will receive cashew immunotherapy daily for 12 months | Other | cashew oral immunotherapy |
Primary outcome
Proportion of consented participants who are eligible for the Ultra-Rush Day
Time frame: Day 1
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
Time frame: Day 1
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
Time frame: Week 2 through to Week 16
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
Time frame: Day1 through to Month 14
72% is defined as successful
Proportion of participants with a treatment-related unexpected serious adverse event
Time frame: Day 1 through to Month 12
This outcome will allow assessment of the safety of the intervention
Proportion of participants who discontinue due to adverse events
Time frame: Day 1 through to Month 12
This will allow assessment of the safety of the intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Amanda Burgess contact
Mimi Tang, Prof principal investigator
Murdoch Childrens Research Institute
Questions about this trial
What is this clinical trial studying?
A study testing cashew oral immunotherapy in people with Food Allergy in Children, run by Murdoch Childrens Research Institute.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Adriana Chebar Lozinsky Rolnik (+61399366435, cashew.study@mcri.edu.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of consented participants who are eligible for the Ultra-Rush Day (time frame: Day 1). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.