Efficacy and Safety of Cashew Nut Oral Immunotherapy in Children

NCT05821621 | Unknown

• 1 other identifier: 2022PI216
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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

Keywords

Cashew nut allergy; Food allergen immunotherapy

Outcome Measures

Primary Outcomes (1)

• Safety

  To evaluate the safety of oral cashew immunotherapy during the dose escalation phase and during the maintenance phase : Frequency of occurrence of at least one allergic reaction during the dose escalation phase and during the first 6 months of maintenance

  during the dose escalation phase and during 6 months of maintenance

Secondary Outcomes (5)

• Frequency of allergic reaction

  during the dose escalation and maintenance phases : first 6 months, 1st year, 2nd year, 3rd year

• Describe the severity of allergic reactions

  during the dose escalation and maintenance phases (first 6 months, 1st year, 2nd year, 3rd year)

• Predictive factors of severe allergic reactions

  during cashew nut immunotherapy

• Factors associated with severe allergic reactions

  during cashew nut immunotherapy

• Immunotherapy discontinuation

  during cashew nut immunotherapy

Study Arms (1)

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)

Other: no intervention

Interventions

no intervention OTHER

observational study : there is no intervention

Cashew nut allergy

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Observational, longitudinal and monocentric epidemiological study carried out in the pediatric allergology department of the Nancy University Hospital. Data collection will be carried out retrospectively. The study does not foresee any new collection of health data. No follow-up will be necessary for the patients of the study.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (1)

Centre Hospitalo-Universitaire de Nancy

Vandœuvre-lès-Nancy, 54511, France

Location

Central Study Contacts

Alexandra Koutzouzian

CONTACT

+33611505692; a.koutzouzian@chru-nancy.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: April 7, 2023
• First Posted: April 20, 2023
• Study Start: April 17, 2023
• Primary Completion: April 17, 2023
• Study Completion: May 30, 2023
• Last Updated: April 20, 2023

Record last verified: 2023-04

Locations

FR (1)