The NACHO Trial (Nut Allergy Children OIT)

Official title

Efficacy of Oral Immunotherapy for Cashew Allergy in Children Aged 1 to 17 Years: a Clinical Prospective Randomized Controlled Interventional Trial

Overview

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.

Interventions

• 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

Primary outcome measures

• Desensitization [Time frame: 12 months]

Secondary outcome measures (4)

• Sustained unresponsiveness [Time frame: 24 months]
• Partial desensitization at 12 months [Time frame: 12 months]
• Partial desensitization at 24 months [Time frame: 24 months]
• Impact on quality of life [Time frame: 24 months]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

• 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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Crossover

Masking

Open label

Primary purpose

Treatment

Study locations

Finland · 1 center

• HUS Skin and Allergy Hospital — Helsinki

Identifiers

NCT: NCT06930950 · HUS/131/2024

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗