Efficacy and Safety of Cashew Nut Oral Immunotherapy in Children (CAJESITO2)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Food Allergy in Children
• Intervention / Treatment: Other: no intervention

• Study Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

• Study Contact: Name: Alexandra Koutzouzian; Phone Number: +33611505692; Email: a.koutzouzian@chru-nancy.fr

Study Locations

• France
  • Vandœuvre-lès-Nancy, France, 54511
    • Centre Hospitalo-Universitaire de Nancy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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; observational study : there is no intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of allergic reaction	To assess the frequency of allergic reactions reactions during the dose escalation and maintenance phases : Frequency of allergic reactions during the dose-escalation and maintenance phases (first 6 months, 1st year, 2nd year, 3rd year)	during the dose escalation and maintenance phases : first 6 months, 1st year, 2nd year, 3rd year
Describe the severity of allergic reactions	Describe the severity of allergic reactions during the dose escalation and maintenance phases : Severity of allergic reactions during the dose escalation and during the maintenance phase (first 6 months, 1st year, 2nd year, 3rd year)	during the dose escalation and maintenance phases (first 6 months, 1st year, 2nd year, 3rd year)
Predictive factors of severe allergic reactions	To identify predictive factors of severe allergic reactions during cashew nut immunotherapy : Predictive factors for the occurrence of severe allergic reactions (age at initiation, atcd of severe allergic reaction, initial threshold, asthma, other food allergy, atopic dermatitis, allergic rhinitis, initial specific IgE levels, ratio IgE rAna o3/cashew ratio)	during cashew nut immunotherapy
Factors associated with severe allergic reactions	identify the factors (during the protocol) associated with severe allergic reactions (cofactor, poor compliance...) : Factors associated with the occurrence of severe allergic reactions (bad compliance, fasting, pollen peak, infection, asthma imbalance, effort, excitement, medication...)	during cashew nut immunotherapy
Immunotherapy discontinuation	Evaluate the frequency of immunotherapy discontinuation and describe its causes	during cashew nut immunotherapy

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France

Study record dates

Study Major Dates

• Study Start (Anticipated): April 17, 2023
• Primary Completion (Anticipated): April 17, 2023
• Study Completion (Anticipated): May 30, 2023

Study Registration Dates

• First Submitted: April 7, 2023
• First Submitted That Met QC Criteria: April 7, 2023
• First Posted (Actual): April 20, 2023

Study Record Updates

• Last Update Posted (Actual): April 20, 2023
• Last Update Submitted That Met QC Criteria: April 7, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Cashew nut allergy; Food allergen immunotherapy
• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Food Hypersensitivity
• Other Study ID Numbers: 2022PI216

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No