Clinical trial NCT06930950: The NACHO Trial (Nut Allergy Children OIT)
Official title: Efficacy of Oral Immunotherapy for Cashew Allergy in Children Aged 1 to 17 Years: a Clinical Prospective Randomized Controlled Interventional Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Oral Immunotherapy for Food Allergy
Tree Nut Allergy
Cashew Nut Allergy
Keywords: Oral immunotherapy
Cashew
Tree Nut
Food allergen immunotherapy
Lead sponsor: HUS Skin and Allergy Hospital
Sponsor class: OTHER
First posted: 2025-04-16
Enrollment: 45
Sex: ALL
Minimum age (years): 1
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: TREATMENT

Brief 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 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.


Eligibility criteria: Inclusion Criteria:

1. Age 6 months - 17 years
2. Sensitization to cashew nut (allergen-specific IgE or positive skin PRICK test)
3. Positive oral food challenge for cashew nut

Exclusion Criteria:

1. Poor adherence
2. Uncontrolled or severe asthma
3. Uncontrolled active or severe or atopic dermatitis
4. Chronic urticaria
5. Eosinophilic esophagitis or other gastrointestinal eosinophilic disorders
6. Active malignant neoplasia
7. Active systemic, autoimmune disease
8. Diabetes treated with insulin
9. Severe systemic illness or severe medical conditions such as cardiovascular or lung diseases
10. Medication with beta blockers
11. Medication with ACE-inhibitors
12. Mastocytosis
13. Pregnancy or breastfeeding
14. Language barriers (not fluent Finnish or Swedish)

Primary outcomes:
measure: Desensitization
timeFrame: 12 months
Secondary outcomes:
measure: Sustained unresponsiveness
timeFrame: 24 months
measure: Partial desensitization at 12 months
timeFrame: 12 months
measure: Partial desensitization at 24 months
timeFrame: 24 months
measure: Impact on quality of life
timeFrame: 24 months
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: HUS Skin and Allergy Hospital
Study officials:
References: