The NACHO Trial (Nut Allergy Children OIT)

Last updated: April 9, 2025
Sponsor: HUS Skin and Allergy Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Allergy (Pediatric)

Allergies & Asthma

Allergy

Treatment

Cashew nut oral immunotherapy

Clinical Study ID

NCT06930950
HUS/131/2024
  • Ages 1-17
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

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 lungdiseases

  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

Total Participants: 45
Treatment Group(s): 1
Primary Treatment: Cashew nut oral immunotherapy
Phase:
Study Start date:
September 13, 2024
Estimated Completion Date:
November 05, 2029

Connect with a study center

  • HUS Skin and Allergy Hospital

    Helsinki,
    Finland

    Active - Recruiting

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