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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 1
Maximum Age: 17
Healthy Volunteers: f
View:

• Age 6 months - 17 years

• Sensitization to cashew nut (allergen-specific IgE or positive skin PRICK test)

• Positive oral food challenge for cashew nut

Locations
Other Locations
Finland
HUS Skin and Allergy Hospital
RECRUITING
Helsinki
Contact Information
Primary
Heidi Sandström, MD
heidi.sandstrom@hus.fi
+358 50 428 7931
Time Frame
Start Date: 2024-09-13
Estimated Completion Date: 2029-11-05
Participants
Target number of participants: 45
Treatments
Active_comparator: Intervention group
The group that will receive oral immunotherapy for cashew nut
No_intervention: Control group
The group that will continue avoiding cashew nut for 12 months before crossover to active OIT to cashew nut
Related Therapeutic Areas
Sponsors
Leads: HUS Skin and Allergy Hospital

This content was sourced from clinicaltrials.gov