Allergy;FoodCAJESITONCT05826405
Efficacy and Safety of Oral Cashew Nut Immunotherapy in Children (CAJESITO)
An observational study of Allergy;Food and Allergy, Nut, run by Central Hospital, Nancy, France.
Trial summary
The objectives of the CAJESITO study are (i) to assess the tolerance of oral cashew nut immunotherapy, by describing the frequency and severity of allergic reactions during oral cashew nut immunotherapy and (ii )to assess the risk factors for severe allergic reactions during oral cashew nut immunotherapy (predictive… Read more about this study
- Who is it for?
- Ages 0 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Allergy;Food, Allergy, Nut
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 10 May 2023to 10 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 0 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: All patients from 0 to 18 years old followed in allergology at the University Hospital of Nancy benefiting from oral immunotherapy with cashew nuts for at least 18 months as of 02/28/2023
Who may be able to join
- Patients under the age of 18 with a proven allergy to cashew nuts and followed in the pediatric allergology unit of the University Hospital of Nancy.
- Patients who have received oral cashew nut immunotherapy for at least 18 months as of 02/28/2023
Who cannot join
- Patients who have received oral cashew nut immunotherapy for less than 18 months.
- Patients lost to follow-up for more than 3 years, i.e. last consultation dating from 2020 or earlier
Trial locations and contacts
No sites are listed yet.
About this study
The objectives of the CAJESITO study are (i) to assess the tolerance of oral cashew nut immunotherapy, by describing the frequency and severity of allergic reactions during oral cashew nut immunotherapy and (ii )to assess the risk factors for severe allergic reactions during oral cashew nut immunotherapy (predictive factors, associated factors.
- Conditions
- Allergy;Food, Allergy, Nut
- Being tested
- No intervention
- Keywords
- allergy, food allergy, cashew nut allergy, oral immunotherapy, pistachio allergy
- Medical subject headings
- Food Hypersensitivity, Nut Hypersensitivity, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention, it's an observational study
| Study group | Role | What they receive |
|---|---|---|
| Cashew Nut allergic | Not described Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of allergic reaction
Measured: during 6 months
Secondary outcomes (8)
Predictive factor of good tolerance
age at onset
Measured: during 6 months
antibody variation
Modification of level of specific IgE and IGg4 with cashew nuts
Measured: during 6 months
sustained unresponsiveness
Tolerance of 1, 2, 4, 8g in isolated doses and 15g in total cumulative dose of cashew nuts during an oral challenge test with cashew nuts 3 months after stopping the daily consumption of 2g of cashew nuts
Measured: 9 months
oral tolerance of pistachio
Tolerance of 1, 2, 4, 8g in isolated doses and 15g in total cumulative dose of pistachio during an oral provocation test with pistachio 3 months after stopping the daily consumption of 2g of cashew nuts
Measured: 6 months
Predictive factor of good tolerance
antecedent of severe allergic reaction
Measured: 6 months
Predictive factor of good tolerance
initial reactogenic threshold
Measured: 6 months
Predictive factor of good tolerance
presence atopy (asthma, food allergy or atopic dermatitis)
Measured: 6 months
Predictive factor of good tolerance
initial specific IgE and Ana o3 levels
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2023
- Study start10 May 2023 (estimated)
- Primary completion10 May 2023 (estimated)
- Study completion10 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergy;FoodStudies 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 40 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
- NCT05826405
- Sponsor's protocol ID
- FORM-03935
- Acronym
- CAJESITO
- Status last verified
- Apr 2023
- First submitted
- 7 Apr 2023
- Last updated
- 24 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 24 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Oral Cashew Nut Immunotherapy in Children (CAJESITO)
- ClinicalTrials.gov ID
- NCT05826405
- Acronym / sponsor ID
- CAJESITO / FORM-03935
- Conditions
- Allergy;Food, Allergy, Nut
- Keywords
- allergy, food allergy, cashew nut allergy, oral immunotherapy, pistachio allergy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 10 May 2023 (estimated)
- Primary completion
- 10 May 2023 (estimated)
- Study completion
- 10 May 2023 (estimated)
- First posted
- 24 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.
The objectives of the CAJESITO study are (i) to assess the tolerance of oral cashew nut immunotherapy, by describing the frequency and severity of allergic reactions during oral cashew nut immunotherapy and (ii )to assess the risk factors for severe allergic reactions during oral cashew nut immunotherapy (predictive factors, associated factors.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cashew Nut allergic | – | Other: No intervention |
Who may qualify
- Ages
- 0 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- All patients from 0 to 18 years old followed in allergology at the University Hospital of Nancy benefiting from oral immunotherapy with cashew nuts for at least 18 months as of 02/28/2023
Key inclusion criteria (2 listed)
- Patients under the age of 18 with a proven allergy to cashew nuts and followed in the pediatric allergology unit of the University Hospital of Nancy.
- Patients who have received oral cashew nut immunotherapy for at least 18 months as of 02/28/2023
Key exclusion criteria (2 listed)
- Patients who have received oral cashew nut immunotherapy for less than 18 months.
- Patients lost to follow-up for more than 3 years, i.e. last consultation dating from 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 interventionNo intervention, it's an observational study | Other | Cashew Nut allergic |
Primary outcome
Number of allergic reaction
Time frame: during 6 months
8 secondary outcomes
Predictive factor of good tolerance
Time frame: during 6 months
antibody variation
Time frame: during 6 months
sustained unresponsiveness
Time frame: 9 months
oral tolerance of pistachio
Time frame: 6 months
Predictive factor of good tolerance
Time frame: 6 months
Predictive factor of good tolerance
Time frame: 6 months
Predictive factor of good tolerance
Time frame: 6 months
Predictive factor of good tolerance
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Allergy;Food and Allergy, Nut, run by Central Hospital, Nancy, 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 24 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
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 Amandine AD DIVARET-CHAUVEAU, MCU PH (+3383153695, a.chauveau@chru-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of allergic reaction (time frame: during 6 months). 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 24 Apr 2023.