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NCT Number: NCT06930950

The NACHO Trial (Nut Allergy Children OIT)

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.

Recruiting

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Key information

Age range

1 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

HUS Skin and Allergy Hospital

Helsinki, Finland

Location status: Recruiting

Location contact

Heidi Sandström MD

CONTACT

[email protected]

+358504287931

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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

Primary outcomes

  1. Desensitization

    Time frame: 12 months

    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.

Secondary outcomes

  1. Sustained unresponsiveness

    Time frame: 24 months

    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.

  2. Partial desensitization at 12 months

    Time frame: 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.

  3. Partial desensitization at 24 months

    Time frame: 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

  4. Impact on quality of life

    Time frame: 24 months

    The proportion of patients who report improved quality of life in the FAQLQ surveys after OIT, compared to their QoL while avoiding cashew nuts

Study contacts

Contact information is provided by the study sponsor or research team.

Heidi Sandström, MD

CONTACT

[email protected]

+358 50 428 7931

Sponsors and collaborators

Lead sponsor

HUS Skin and Allergy Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2029
Study completion
2029
First posted
Apr 16, 2025
Registry last updated
Apr 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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