Oral Immunotherapy for Food AllergyNCT06930950
The NACHO Trial (Nut Allergy Children OIT)
A study testing Cashew nut oral immunotherapy in people with Oral Immunotherapy for Food Allergy and Tree Nut Allergy, run by HUS Skin and Allergy Hospital at 1 site in Finland.
Trial summary
Most food allergies that begin in early childhood are mild and resolve by school age, but nut allergies persist in about 80-90% of individuals into adulthood. The consumption of nuts, particularly cashew nuts, has increased dramatically in Finland in the 21st century, leading to a rise in severe allergic reactions to… Read more about this study
- Who is it for?
- Ages 1 year to 17 years
- Conditions the study is for
- Oral Immunotherapy for Food Allergy, Tree Nut Allergy, Cashew Nut Allergy
- What is being tested?
- Cashew nut oral immunotherapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteFinland
- Study dates
- 13 Sep 2024to 5 Nov 2029
- 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 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 6 months - 17 years
- Sensitization to cashew nut (allergen-specific IgE or positive skin PRICK test)
- Positive oral food challenge for cashew nut
Who cannot join
- Poor adherence
- Uncontrolled or severe asthma
- Uncontrolled active or severe or atopic dermatitis
- Chronic urticaria
- Eosinophilic esophagitis or other gastrointestinal eosinophilic disorders
- Active malignant neoplasia
Show all 14Show fewer
- Active systemic, autoimmune disease
- Diabetes treated with insulin
- Severe systemic illness or severe medical conditions such as cardiovascular or lung diseases
- Medication with beta blockers
- Medication with ACE-inhibitors
- Mastocytosis
- Pregnancy or breastfeeding
- Language barriers (not fluent Finnish or Swedish)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Finland1 site, 1 recruiting
- Recruiting
HUS Skin and Allergy Hospital
Helsinki
Heidi Sandström MD, +358504287931, heidi.sandstrom@hus.fi
About this study
Official title: Efficacy of Oral Immunotherapy for Cashew Allergy in Children Aged 1 to 17 Years: a Clinical Prospective Randomized Controlled Interventional Trial
Most food allergies that begin in early childhood are mild and resolve by school age, but nut allergies persist in about 80-90% of individuals into adulthood. The consumption of nuts, particularly cashew nuts, has increased dramatically in Finland in the 21st century, leading to a rise in severe allergic reactions to cashew nuts among young children. Of the food anaphylaxis cases reported in the Finnish Anaphylaxis Registry between 2015-2020, 49% were caused by nuts, with cashew nuts being the most common trigger. The standard treatment for nut allergies is strict avoidance of nuts and symptom management with emergency medications.
Oral immunotherapy (OIT) is a food allergy treatment that increases tolerance, and it has primarily been studied in school-aged children, with desensitization achieved in about 80% of cases. Permanent tolerance, depending on the allergen, develops in 30-50% of cases within five years. International guidelines recommend peanut OIT for children over the age of 4 who have severe peanut allergies. The likelihood of achieving tolerance, especially permanent tolerance, appears to improve the earlier the treatment is started. To date, only one study (NUIT CRACKER) has been published on cashew nut desensitization in children over 4 years old, involving 50 children, where 88% achieved desensitization to both cashew nuts and pistachios.
The aim of this study is to develop a cashew nut desensitization protocol and investigate its effectiveness in achieving tolerance and permanent desensitization in children aged 1-17 years, compared to cashew nut avoidance. The study will assess the safety of cashew nut desensitization and its impact on the quality of life of patients and their families.
- Being tested
- Cashew nut oral immunotherapy
- Keywords
- Oral immunotherapy, Cashew, Tree Nut, Food allergen immunotherapy
- Medical subject headings
- Nut Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cashew nut oral immunotherapyOther
Cashew nut oral immunotherapy (OIT) where the aim is desensitizing individuals with cashew nut allergies. The approach involves the gradual administration of increasing doses of cashew nut protein. The goal of OIT is to increase the threshold of tolerance to cashew nuts, thereby reducing the risk of severe allergic reactions upon accidental exposure
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Active comparator | The group that will receive oral immunotherapy for cashew nut Receives: Other: Cashew nut oral immunotherapy |
| Control group | No intervention | The group that will continue avoiding cashew nut for 12 months before crossover to active OIT to cashew nut |
What is being measured
The primary outcome is the main question the study is designed to answer.
Desensitization
The proportion of patients able to tolerate the target dose of 1000 mg of cashew nut protein in an Oral Food Challenge (OFC) after 12 months of Oral Immunotherapy (OIT) compared to the control group.
Measured: 12 months
Secondary outcomes (4)
Sustained unresponsiveness
The proportion of patients able to tolerate 1000mg of cashew nut protein in an OFC after 23 months of OIT followed by one month of avoidance.
Measured: 24 months
Partial desensitization at 12 months
The proportion of patients able to tolerate a dose below 1000mg of cashew nut protein in an OFC after 12 months of OIT compared to the control group.
Measured: 12 months
Partial desensitization at 24 months
The proportion of patients able to tolerate a dose below 1000 mg of cashew nut protein in an OFC after 23 months of OIT followed by one month of avoidance
Measured: 24 months
Impact on quality of life
The proportion of patients who report improved quality of life in the FAQLQ surveys after OIT, compared to their QoL while avoiding cashew nuts
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2025
- Study start13 Sep 2024
- Primary completion5 Nov 2029 (estimated)
- Study completion5 Nov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral Immunotherapy for Food AllergyStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Crossover
- Model description
- All patients taking part of the trial will be randomized by simple randomization to the active OIT or control group in a 2:1 manner. Patients will be assigned to a treatment group according to the randomization. The control group will crossover to OIT after 12 months of cashew nut avoidance, after a new OFC is done.
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HUS Skin and Allergy Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heidi Sandström, HUS Skin and Allergy Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06930950
- Sponsor's protocol ID
- HUS/131/2024
- Status last verified
- Apr 2025
- First submitted
- 9 Apr 2025
- Last updated
- 16 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Oral Immunotherapy for Cashew Allergy in Children Aged 1 to 17 Years: a Clinical Prospective Randomized Controlled Interventional Trial
- ClinicalTrials.gov ID
- NCT06930950
- Acronym / sponsor ID
- HUS/131/2024
- Keywords
- Oral immunotherapy, Cashew, Tree Nut, Food allergen immunotherapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- HUS Skin and Allergy HospitalUniversity, hospital or other
- Study start
- 13 Sep 2024 (actual)
- Primary completion
- 5 Nov 2029 (estimated)
- Study completion
- 5 Nov 2029 (estimated)
- First posted
- 16 Apr 2025 (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.
Most food allergies that begin in early childhood are mild and resolve by school age, but nut allergies persist in about 80-90% of individuals into adulthood. The consumption of nuts, particularly cashew nuts, has increased dramatically in Finland in the 21st century, leading to a rise in severe allergic reactions to cashew nuts among young children. Of the food anaphylaxis cases reported in the Finnish Anaphylaxis Registry between 2015-2020, 49% were caused by nuts, with cashew nuts being the most common trigger. The standard treatment for nut allergies is strict avoidance of nuts and symptom management with emergency medications.
Oral immunotherapy (OIT) is a food allergy treatment that increases tolerance, and it has primarily been studied in school-aged children, with desensitization achieved in about 80% of cases. Permanent tolerance, depending on the allergen, develops in 30-50% of cases within five years. International guidelines recommend peanut OIT for children over the age of 4 who have severe peanut allergies. The likelihood of achieving tolerance, especially permanent tolerance, appears to improve the earlier the treatment is started. To date, only one study (NUIT CRACKER) has been published on cashew nut desensitization in children over 4 years old, involving 50 children, where 88% achieved desensitization to both cashew nuts and pistachios.
The aim of this study is to develop a cashew nut desensitization protocol and investigate its effectiveness in achieving tolerance and permanent desensitization in children aged 1-17 years, compared to cashew nut avoidance. The study will assess the safety of cashew nut desensitization and its impact on the quality of life of patients and their families.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- All patients taking part of the trial will be randomized by simple randomization to the active OIT or control group in a 2:1 manner. Patients will be assigned to a treatment group according to the randomization. The control group will crossover to OIT after 12 months of cashew nut avoidance, after a new OFC is done.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Active comparator | Other: Cashew nut oral immunotherapyThe group that will receive oral immunotherapy for cashew nut |
| Control group | No intervention | –The group that will continue avoiding cashew nut for 12 months before crossover to active OIT to cashew nut |
Who may qualify
- Ages
- 1 year to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Age 6 months - 17 years
- Sensitization to cashew nut (allergen-specific IgE or positive skin PRICK test)
- Positive oral food challenge for cashew nut
Key exclusion criteria (14 listed)
- Poor adherence
- Uncontrolled or severe asthma
- Uncontrolled active or severe or atopic dermatitis
- Chronic urticaria
- Eosinophilic esophagitis or other gastrointestinal eosinophilic disorders
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 nut oral immunotherapyCashew nut oral immunotherapy (OIT) where the aim is desensitizing individuals with cashew nut allergies. The approach involves the gradual administration of increasing doses of cashew nut protein. The goal of OIT is to increase the threshold of tolerance to cashew nuts, thereby reducing the risk of severe allergic reactions upon accidental exposure | Other | Intervention group |
Primary outcome
Desensitization
Time frame: 12 months
The proportion of patients able to tolerate the target dose of 1000 mg of cashew nut protein in an Oral Food Challenge (OFC) after 12 months of Oral Immunotherapy (OIT) compared to the control group.
4 secondary outcomes
Sustained unresponsiveness
Time frame: 24 months
Partial desensitization at 12 months
Time frame: 12 months
Partial desensitization at 24 months
Time frame: 24 months
Impact on quality of life
Time frame: 24 months
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 16 Apr 2025.
- Individual participant dataSharing planned: No
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A Randomized Controlled Trial of Oral Immunotherapy Versus Allergen Avoidance in Children Under 2 Years With Food Allergy
Food Allergy in Children, Oral Immunotherapy for Food Allergy
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Multi-Food Oral Immunotherapy for Peanut and Tree Nuts
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Understanding the Immune System's Role in Tree Nut and Peanut Allergies: Key Biomarkers for Diagnosis and Treatment Monitoring and Treatment Targets
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cashew nut oral immunotherapy in people with Oral Immunotherapy for Food Allergy and Tree Nut Allergy, run by HUS Skin and Allergy Hospital at 1 site in Finland.
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 3 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 16 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Heidi Sandström, MD (+358 50 428 7931, heidi.sandstrom@hus.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Desensitization (time frame: 12 months). 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 16 Apr 2025; AzTrials last refreshed its copy on 26 Oct 2026.