Efficacy and Safety of Cashew Nut Oral Immunotherapy in Children

NCT ID: NCT05821621

Last Updated: 2023-04-20

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-04-17
• Study Completion Date: 2023-05-30

Brief Summary

Allergy to nuts (cashew, pistachio, walnut, exotic nuts) is a frequent allergy in children, with a prevalence of up to 4.9% of the population and a low resolution rate (9%). Among the nut allergies, cashew nut allergy is one of the most frequent in Northern Europe: in France 41% of children allergic to nuts are sensitized to cashew nuts. Moreover, cashew nut allergy is associated with severe reactions that can be lethal in both adults and children. These reactions may even be more severe than those observed with peanuts, with more frequent respiratory and cardiovascular impairment. We note reactions for even limited contacts (cutaneous or mucous) and low reactogenic thresholds. However, the only recommendation for management at present is avoidance. The stakes of oral immunotherapy protocols cashew would be similar to those for peanut immunotherapy: to limit reactions in case of accidental intake, increase the reactogenic threshold and thus improve the quality of life of allergic patients.

To date, only one study has focused on the efficacy and tolerance of cashew immunotherapy : the prospective NUT CRACKER study conducted on 50 children aged 4 years or older with cashew nut allergy between 2016 and 2019, reports a good efficacy of immunotherapy on increasing threshold for cashew nut but also for pistachio and walnut, when there was a cross-over allergy. While the tolerance was similar to other immunotherapy protocols for the other foods.

The objectives of part 2 of the CAJESITO study are (i) to evaluate the tolerance of oral cashew nut immunotherapy, by describing the frequency and severity of allergic reactions during oral cashew immunotherapy and (ii) to identify risk factors for severe risk factors for severe allergic reactions during oral cashew immunotherapy.

Conditions

Food Allergy in Children

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Cashew nut allergy

Inclusion criteria:

• Patients under 18 years of age with a proven allergy to cashew nut and followed in the pediatric allergology unit of Nancy University Hospital.
• Patients having received oral cashew immunotherapy for at least 18 months at 28/02/2023

Non-inclusion criteria:

• Patients who have received oral cashew immunotherapy for less than 18 months.
• Patients lost to follow-up for more than 3 years (last consultation in 2020 or earlier)

no intervention

Intervention Type: OTHER

observational study : there is no intervention

Interventions

no intervention

observational study : there is no intervention

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patients under 18 years of age with a known allergy to cashew nuts cashew nut allergy and followed in the pediatric allergology unit of Nancy University Hospital.
• Patients who have received oral cashew immunotherapy for at least 18 months at 28/02/2023

Exclusion Criteria

• Patients who have received oral cashew immunotherapy for less than for less than 18 months.
• Patients lost to follow-up for more than 3 years (last visit in 2020 or earlier)

• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Central Hospital, Nancy, France

OTHER

Sponsor Role: lead

Responsible Party

Amandine DIVARET-CHAUVEAU

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Centre Hospitalo-Universitaire de Nancy

Vandœuvre-lès-Nancy, , France

Countries

France

Central Contacts

Alexandra Koutzouzian

Role: CONTACT

a.koutzouzian@chru-nancy.fr

+33611505692

Other Identifiers

2022PI216

Identifier Type: -

Identifier Source: org_study_id