An interventional study of Cashew nut oral immunotherapy in Oral Immunotherapy for Food Allergy, Tree Nut Allergy and Cashew Nut Allergy, sponsored by HUS Skin and Allergy Hospital. Recruiting at 1 site in Finland. Open to participants aged 1 Year to 17 Years. Per ClinicalTrials.gov, last updated 2025-04-16.
Sponsored by HUS Skin and Allergy Hospital · Not applicable, Interventional, and Treatment
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.
33 studies on the registry are indexed under Nut Hypersensitivity; 9 are open to participants now.
This study's planned enrollment of 45 is close to the median of 47 across 20 interventional studies indexed under Nut Hypersensitivity.
Browse Nut Hypersensitivity studies →HUS Skin and Allergy Hospital is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The group that will receive oral immunotherapy for cashew nut
Other: Cashew nut oral immunotherapy
The group that will continue avoiding cashew nut for 12 months before crossover to active OIT to cashew nut
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
Desensitization
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.
Time frame: 12 months
Sustained unresponsiveness
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.
Time frame: 24 months
Partial desensitization at 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.
Time frame: 12 months
Partial desensitization at 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
Time frame: 24 months
Impact on quality of life
The proportion of patients who report improved quality of life in the FAQLQ surveys after OIT, compared to their QoL while avoiding cashew nuts
Time frame: 24 months
Plan to share: No
No publications or documents are linked to this record.
Started Sep 2024 (actual). Primary completion is estimated for Nov 2029, 61 months after the start.
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HUS Skin and Allergy Hospital