The NACHO Trial (Nut Allergy Children OIT)

NCT ID: NCT06930950

Last Updated: 2025-04-16

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-13
• Study Completion Date: 2029-11-05

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention group

The group that will receive oral immunotherapy for cashew nut

Group Type: ACTIVE_COMPARATOR

Cashew nut oral immunotherapy

Intervention Type: OTHER

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

Control group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Cashew nut oral immunotherapy

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

Intervention Type: OTHER

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)

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

HUS Skin and Allergy Hospital

OTHER

Sponsor Role: lead

Responsible Party

Heidi Sandström

Medical Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

HUS Skin and Allergy Hospital

Helsinki, , Finland

Site Status: RECRUITING

Countries

Finland

Central Contacts

Heidi Sandström, MD

Role: CONTACT

heidi.sandstrom@hus.fi

+358 50 428 7931

Facility Contacts

Heidi Sandström MD

Role: primary

heidi.sandstrom@hus.fi

+358504287931

Other Identifiers

HUS/131/2024

Identifier Type: -

Identifier Source: org_study_id