Efficacy and Safety of Cashew Nut Oral Immunotherapy in Children

Food Allergy in Children Clinical Trial

— CAJESITO2  

Official title:

Efficacy and Safety of Cashew Nut Oral Immunotherapy in Children

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05821621
• Other study ID #: 2022PI216
• Status: Not yet recruiting
• Start date: April 17, 2023
• Est. completion date: May 30, 2023

Study information

• Verified date: April 2023
• Source: Central Hospital, Nancy, France
• Contact: Alexandra Koutzouzian
• Phone: +33611505692
• Email: a.koutzouzian[@]chru-nancy.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: May 30, 2023
• Est. primary completion date: April 17, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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)

Related Conditions & MeSH terms

• Food Allergy in Children
• Food Hypersensitivity

Intervention

Other:
• no intervention
observational study : there is no intervention

Locations

Country	Name	City	State
France	Centre Hospitalo-Universitaire de Nancy	Vandœuvre-lès-Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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)
Secondary	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
Secondary	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
Secondary	Immunotherapy discontinuation	Evaluate the frequency of immunotherapy discontinuation and describe its causes	during cashew nut immunotherapy