The NACHO Trial (Nut Allergy Children OIT)

HUS Skin and Allergy Hospital

Status: Enrolling

Conditions: Cashew Nut Allergy; Tree Nut Allergy; Oral Immunotherapy for Food Allergy

Treatments: Other: Cashew nut oral immunotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06930950

HUS/131/2024

Details and patient eligibility

About

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.

Enrollment: 45 estimated patients

Sex: All

Ages: 1 to 17 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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45 participants in 2 patient groups

Intervention group

Active Comparator group

Description:

The group that will receive oral immunotherapy for cashew nut

Treatment:

Other: Cashew nut oral immunotherapy

Control group

No Intervention group

Description:

The group that will continue avoiding cashew nut for 12 months before crossover to active OIT to cashew nut