Clinical trial NCT05821621: Efficacy and Safety of Cashew Nut Oral Immunotherapy in Children
Official title: Efficacy and Safety of Cashew Nut Oral Immunotherapy in Children
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Food Allergy in Children
Keywords: Cashew nut allergy
Food allergen immunotherapy
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2023-04-20
Enrollment: 50
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.


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)

Primary outcomes:
measure: Safety
timeFrame: during the dose escalation phase and during 6 months of maintenance
Secondary outcomes:
measure: Frequency of allergic reaction
timeFrame: during the dose escalation and maintenance phases : first 6 months, 1st year, 2nd year, 3rd year
measure: Describe the severity of allergic reactions
timeFrame: during the dose escalation and maintenance phases (first 6 months, 1st year, 2nd year, 3rd year)
measure: Predictive factors of severe allergic reactions
timeFrame: during cashew nut immunotherapy
measure: Factors associated with severe allergic reactions
timeFrame: during cashew nut immunotherapy
measure: Immunotherapy discontinuation
timeFrame: during cashew nut immunotherapy
Other outcomes:
Locations:
city: Vandœuvre-lès-Nancy
country: France
facility: Centre Hospitalo-Universitaire de Nancy
Study officials:
References: