The NACHO Trial (Nut Allergy Children OIT)

Официальное название

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

Обзор

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.

Вмешательства

• Другое 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

Первичные конечные точки

• Desensitization [Срок оценки: 12 months]

Вторичные конечные точки (4)

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

Критерии участия

Критерии включения

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

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Финляндия · 1 центр

• HUS Skin and Allergy Hospital — Helsinki

Идентификаторы

NCT: NCT06930950 · HUS/131/2024

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗