The NACHO Trial (Nut Allergy Children OIT)

Not Applicable

Recruiting

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

• Registration Number: NCT06930950
• Lead Sponsor: HUS Skin and Allergy Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-09-13
• Status Verified: 2025-04
• Study First Submitted: 2025-04-09
• Study First Submitted QC: 2025-04-09
• Last Update Submitted: 2025-04-09
• Study First Posted: 2025-04-16
• Last Update Posted: 2025-04-16
• Primary Completion: 2029-11-05
• Study Completion: 2029-11-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 45

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Desensitization	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.

Secondary Outcome Measures

Name	Time	Method
Sustained unresponsiveness	24 months	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.
Partial desensitization at 12 months	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.
Partial desensitization at 24 months	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
Impact on quality of life	24 months	The proportion of patients who report improved quality of life in the FAQLQ surveys after OIT, compared to their QoL while avoiding cashew nuts

Trial Locations

Locations (1)

HUS Skin and Allergy Hospital; 🇫🇮 Helsinki, Finland