Food Allergy in ChildrenCAJESITO2NCT05821621
Efficacy and Safety of Cashew Nut Oral Immunotherapy in Children
An observational study of Food Allergy in Children, run by Central Hospital, Nancy, France at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Food Allergy in Children
- Type of treatment
- Pill or oral medicine
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 17 Apr 2023to 30 May 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
France1 site
Centre Hospitalo-Universitaire de Nancy
Vandœuvre-lès-Nancy, 54511
About this study
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
- Being tested
- no intervention
- Keywords
- Cashew nut allergy, Food allergen immunotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
observational study : there is no intervention
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: during the dose escalation phase and during 6 months of maintenance
Secondary outcomes (5)
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)
Measured: 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)
Measured: 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)
Measured: 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...)
Measured: during cashew nut immunotherapy
Immunotherapy discontinuation
Evaluate the frequency of immunotherapy discontinuation and describe its causes
Measured: during cashew nut immunotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2023
- Study start17 Apr 2023 (estimated)
- Primary completion17 Apr 2023 (estimated)
- Study completion30 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Food Allergy in ChildrenStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amandine DIVARET-CHAUVEAU, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05821621
- Sponsor's protocol ID
- 2022PI216
- Acronym
- CAJESITO2
- Status last verified
- Apr 2023
- First submitted
- 7 Apr 2023
- Last updated
- 20 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Cashew Nut Oral Immunotherapy in Children
- ClinicalTrials.gov ID
- NCT05821621
- Acronym / sponsor ID
- CAJESITO2 / 2022PI216
- Conditions
- Food Allergy in Children
- Keywords
- Cashew nut allergy, Food allergen immunotherapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 17 Apr 2023 (estimated)
- Primary completion
- 17 Apr 2023 (estimated)
- Study completion
- 30 May 2023 (estimated)
- First posted
- 20 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cashew nut allergy | – | Other: no interventionInclusion 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) |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no interventionobservational study : there is no intervention | Other | Cashew nut allergy |
Primary outcome
Safety
Time frame: during the dose escalation phase and during 6 months of maintenance
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
5 secondary outcomes
Frequency of allergic reaction
Time frame: during the dose escalation and maintenance phases : first 6 months, 1st year, 2nd year, 3rd year
Describe the severity of allergic reactions
Time frame: during the dose escalation and maintenance phases (first 6 months, 1st year, 2nd year, 3rd year)
Predictive factors of severe allergic reactions
Time frame: during cashew nut immunotherapy
Factors associated with severe allergic reactions
Time frame: during cashew nut immunotherapy
Immunotherapy discontinuation
Time frame: during cashew nut immunotherapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Food Allergy in Children, run by Central Hospital, Nancy, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alexandra Koutzouzian (+33611505692, a.koutzouzian@chru-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety (time frame: during the dose escalation phase and during 6 months of maintenance). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2023.