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NCT06930950
The NACHO Trial (Nut Allergy Children OIT)
NA trial testing Cashew nut oral immunotherapy in Oral Immunotherapy for Food Allergy in 45 participants. Currently enrolling.
5 November 2029
Quick facts
| Lead sponsor | HUS Skin and Allergy Hospital |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 45 |
| Start date | 13 September 2024 |
| Primary completion | 5 November 2029 |
| Estimated completion | 5 November 2029 |
| Sites | 1 location across Finland |
Drugs / interventions tested
- Cashew nut oral immunotherapy
Conditions studied
- Oral Immunotherapy for Food Allergy — all drugs for Oral Immunotherapy for Food Allergy →
- Tree Nut Allergy — all drugs for Tree Nut Allergy →
- Cashew Nut Allergy — all drugs for Cashew Nut Allergy →
Sponsor
HUS Skin and Allergy Hospital
Who can join
Adults 1 to 17, any sex, with Oral Immunotherapy for Food Allergy or Tree Nut Allergy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
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Related trials
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06930950 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by HUS Skin and Allergy Hospital
- Last refreshed: 16 April 2025
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