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

Sponsor

Central Hospital, Nancy, France (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05826405

Collaborator

(none)

Enrollment

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Allergy;Food Allergy, Nut	Other: No intervention

Study Design

Study Type:

Observational

Anticipated Enrollment :

40 participants

Observational Model:

Case-Only

Time Perspective:

Retrospective

Official Title:

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

Anticipated Study Start Date :

May 10, 2023

Anticipated Primary Completion Date :

May 10, 2023

Anticipated Study Completion Date :

May 10, 2023

Arms and Interventions

Arm	Intervention/Treatment
Cashew Nut allergic	Other: No intervention No intervention, it's an observational study

Arm

Intervention/Treatment

Cashew Nut allergic

Other: No intervention

No intervention, it's an observational study

Outcome Measures

Primary Outcome Measures

Number of allergic reaction [during 6 months]

Secondary Outcome Measures

Predictive factor of good tolerance [during 6 months]
age at onset
antibody variation [during 6 months]
Modification of level of specific IgE and IGg4 with cashew nuts
sustained unresponsiveness [9 months]
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
oral tolerance of pistachio [6 months]
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
Predictive factor of good tolerance [6 months]
antecedent of severe allergic reaction
Predictive factor of good tolerance [6 months]
initial reactogenic threshold
Predictive factor of good tolerance [6 months]
presence atopy (asthma, food allergy or atopic dermatitis)
Predictive factor of good tolerance [6 months]
initial specific IgE and Ana o3 levels

Eligibility Criteria

Criteria

Ages Eligible for Study:

0 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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