The NACHO Trial (Nut Allergy Children OIT)

NCT06930950 | Recruiting

• 1 other identifier: HUS/131/2024
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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

Keywords

Oral immunotherapy; Cashew; Tree Nut; Food allergen immunotherapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Sustained unresponsiveness

  24 months

• Partial desensitization at 12 months

  12 months

• Partial desensitization at 24 months

  24 months

• Impact on quality of life

  24 months

Study Arms (2)

Intervention group

ACTIVE COMPARATOR

The group that will receive oral immunotherapy for cashew nut

Other: Cashew nut oral immunotherapy

Control group

NO INTERVENTION

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

Interventions

Cashew nut oral immunotherapy 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

Intervention group

Eligibility Criteria

• Age: 1 Year - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• Poor adherence
• Uncontrolled or severe asthma
• Uncontrolled active or severe or atopic dermatitis
• Chronic urticaria
• Eosinophilic esophagitis or other gastrointestinal eosinophilic disorders
• Active malignant neoplasia
• Active systemic, autoimmune disease
• Diabetes treated with insulin
• Severe systemic illness or severe medical conditions such as cardiovascular or lung diseases
• Medication with beta blockers
• Medication with ACE-inhibitors
• Mastocytosis
• Pregnancy or breastfeeding
• Language barriers (not fluent Finnish or Swedish)

Sponsors & Collaborators

• HUS Skin and Allergy Hospital: lead

Study Sites (1)

HUS Skin and Allergy Hospital

Helsinki, Finland

RECRUITING

MeSH Terms

Conditions

Nut Hypersensitivity

Condition Hierarchy (Ancestors)

Nut and Peanut Hypersensitivity; Food Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Central Study Contacts

Heidi Sandström, MD

CONTACT

+358 50 428 7931; heidi.sandstrom@hus.fi

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Model Details: 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.

Study Record Dates

• First Submitted: April 9, 2025
• First Posted: April 16, 2025
• Study Start: September 13, 2024
• Primary Completion (Estimated): November 5, 2029
• Study Completion (Estimated): November 5, 2029
• Last Updated: April 16, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)