Efficacy and Safety of Oral Cashew Nut Immunotherapy in Children (CAJESITO)

Study Overview
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Brief Summary
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The objectives of the CAJESITO study are (i) to assess the tolerance of oral cashew nut immunotherapy, by describing the frequency and severity of allergic reactions during oral cashew nut immunotherapy and (ii )to assess the risk factors for severe allergic reactions during oral cashew nut immunotherapy (predictive factors, associated factors.

Official Title
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Efficacy and Safety of Oral Cashew Nut Immunotherapy in Children (CAJESITO)

Conditions
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Allergy;Food, Allergy, Nut

Intervention / Treatment
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* Other: No intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients under the age of 18 with a proven allergy to cashew nuts and followed in the pediatric allergology unit of the University Hospital of Nancy. Patients who have received oral cashew nut immunotherapy for at least 18 months as of 02/28/2023 Exclusion Criteria: Patients who have received oral cashew nut immunotherapy for less than 18 months. Patients lost to follow-up for more than 3 years, i.e. last consultation dating from 2020 or earlier

Ages Eligible for Study
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Minimum Age: 0 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cashew Nut allergic<br> | Other: No intervention<br>* No intervention, it's an observational study<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of allergic reaction |  | during 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Predictive factor of good tolerance | age at onset | during 6 months | 
| antibody variation | Modification of level of specific IgE and IGg4 with cashew nuts | during 6 months | 
| sustained unresponsiveness | Tolerance of 1, 2, 4, 8g in isolated doses and 15g in total cumulative dose of cashew nuts during an oral challenge test with cashew nuts 3 months after stopping the daily consumption of 2g of cashew nuts | 9 months | 
| oral tolerance of pistachio | Tolerance of 1, 2, 4, 8g in isolated doses and 15g in total cumulative dose of pistachio during an oral provocation test with pistachio 3 months after stopping the daily consumption of 2g of cashew nuts | 6 months | 
| Predictive factor of good tolerance | antecedent of severe allergic reaction | 6 months | 
| Predictive factor of good tolerance | initial reactogenic threshold | 6 months | 
| Predictive factor of good tolerance | presence atopy (asthma, food allergy or atopic dermatitis) | 6 months | 
| Predictive factor of good tolerance | initial specific IgE and Ana o3 levels | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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oral immunotherapy, allergy, food allergy, cashew nut allergy, pistachio allergy