The NACHO Trial (Nut Allergy Children OIT)

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.

Study Overview

• Status: Recruiting
• Conditions: Tree Nut Allergy; Oral Immunotherapy for Food Allergy; Cashew Nut Allergy
• Intervention / Treatment: Other: Cashew nut oral immunotherapy

• Study Type: Interventional
• Enrollment (Estimated): 45
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Heidi Sandström, MD; Phone Number: +358 50 428 7931; Email: heidi.sandstrom@hus.fi

Study Locations

• Finland
  • Helsinki, Finland
    • Recruiting
    • HUS Skin and Allergy Hospital
    • Contact: Heidi Sandström MD; Phone Number: +358504287931; Email: heidi.sandstrom@hus.fi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intervention group; The group that will receive oral immunotherapy for cashew nut	Other: 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
No Intervention: Control group; The group that will continue avoiding cashew nut for 12 months before crossover to active OIT to cashew nut

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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	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	24 months

Collaborators and Investigators

• Sponsor: HUS Skin and Allergy Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 13, 2024
• Primary Completion (Estimated): November 5, 2029
• Study Completion (Estimated): November 5, 2029

Study Registration Dates

• First Submitted: April 9, 2025
• First Submitted That Met QC Criteria: April 9, 2025
• First Posted (Actual): April 16, 2025

Study Record Updates

• Last Update Posted (Actual): April 16, 2025
• Last Update Submitted That Met QC Criteria: April 9, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Oral immunotherapy; Cashew; Food allergen immunotherapy; Tree Nut
• Additional Relevant MeSH Terms: Nut and Peanut Hypersensitivity; Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Food Hypersensitivity; Nut Hypersensitivity; Immunologic Factors; Physiological Effects of Drugs; Immunomodulating Agents
• Other Study ID Numbers: HUS/131/2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No