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

Allergy;Food Clinical Trial

— CAJESITO  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05826405
• Other study ID #: FORM-03935
• Status: Not yet recruiting
• Start date: May 10, 2023
• Est. completion date: May 10, 2023

Study information

• Verified date: April 2023
• Source: Central Hospital, Nancy, France
• Contact: Amandine AD DIVARET-CHAUVEAU, MCU PH
• Phone: +3383153695
• Email: a.chauveau[@]chru-nancy.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: May 10, 2023
• Est. primary completion date: May 10, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 0 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Allergy, Nut
• Allergy;Food
• Food Hypersensitivity
• Hypersensitivity
• Nut Hypersensitivity

Intervention

Other:
• No intervention
No intervention, it's an observational study

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of allergic reaction		during 6 months
Secondary	Predictive factor of good tolerance	age at onset	during 6 months
Secondary	antibody variation	Modification of level of specific IgE and IGg4 with cashew nuts	during 6 months
Secondary	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
Secondary	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
Secondary	Predictive factor of good tolerance	antecedent of severe allergic reaction	6 months
Secondary	Predictive factor of good tolerance	initial reactogenic threshold	6 months
Secondary	Predictive factor of good tolerance	presence atopy (asthma, food allergy or atopic dermatitis)	6 months
Secondary	Predictive factor of good tolerance	initial specific IgE and Ana o3 levels	6 months