AllergyNCT06589232
Threshold Dose Distribution for Pistachio Allergy
An observational study of Allergy and Food Allergy, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
The main objective of this study is to describe the distribution of reactogenic thresholds for pistachio. The secondary objectives are to 1) describe the clinical severity of allergic reactions to pistachio in an oral challenge test, 2) compare the reactogenic thresholds of pistachio and cashew nut on matched data and… Read more about this study
- Who is it for?
- Ages 1 year to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Allergy, Food Allergy
- What is being tested?
- Food allergy
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2021to 9 Apr 2024
- 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 1 year to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Patients under 18 years of age who had a positive pistachio challenge test between January 2021 and December 2023, in the pediatric allergology unit of the Nancy CHRU
Who may be able to join
- Patients under 18 years of age who had a positive pistachio challenge test between January 2021 and December 2023, in the pediatric allergology unit of the Nancy CHRU.
Who cannot join
- Patients who had a questionable oral pistachio provocation test.
- Patients who had a negative pistachio oral provocation test.
Trial locations and contacts
1 site in 1 country.
France1 site
Centre Hospitalo-Universitaire de Nancy
Vandœuvre-lès-Nancy, France, 54511
About this study
Official title: Threshold Dose Distribution for Pistachio Allergy in Children
The main objective of this study is to describe the distribution of reactogenic thresholds for pistachio. The secondary objectives are to 1) describe the clinical severity of allergic reactions to pistachio in an oral challenge test, 2) compare the reactogenic thresholds of pistachio and cashew nut on matched data and 3) evaluate predictive factors of a low reactogenic threshold
Read the detailed description
Nuts, including almonds, walnuts, cashews, pistachio and hazelnut, are among the food allergens most frequently involved in food allergies in children with an estimated prevalence. between 0.05 and 4.9%.
According to data from the Allergo-Vigilance Network, peanuts and the group of nuts, led by cashews, are alone responsible for 51.4% of food anaphylaxis in children.
The pistachio belongs to the same botanical family as the cashew nut (Anacardiumouest) and the mango (Mangifera indica): the anacardiaceae. Botanically, pistachio and cashew are closely related and can both be responsible for moderate to severe immediate allergic reactions. Furthermore, in a previous publication by the team, co-sensitization to pistachio was observed in 98% of children allergic to cashew nuts with only 34% confirmed allergic to pistachio.
In the case of allergy to both anacardiaceae, in a small number of patients, the investigators reported a reactogenic threshold for pistachio greater than or equal to that for cashew nuts.
To our knowledge, there is currently only one study that has evaluated the reactogenic threshold for pistachio, compared to other nuts.
- Conditions
- Allergy, Food Allergy
- Being tested
- Food allergy
- Medical subject headings
- Hypersensitivity, Food Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Food allergyOther
Threshold dose to pistachio
| Study group | Role | What they receive |
|---|---|---|
| Food allergy | Threshold dose to pistachio Receives: Other: Food allergy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Threshold dose to pistachio
in mg of protein
Measured: in the 4 hours of monitoring
Secondary outcomes (2)
Threshold dose to cashew
in mg of proteins
Measured: in the 4 hours of monitoring
Severity of the reaction during a positive pistachio oral provocation test
defined by the COFAR (Consortium for Food Allergy Research) classification, from 1 to 5 and 1 is for mild symptoms
Measured: in the 4 hours of monitoring
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Jan 2021
- Primary completion1 Apr 2024
- Study completion9 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AllergyStudies of the same condition, open and under way.
- 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 (actual)
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
- Investigators
- Amandine DIVARET-CHAUVEAU, Principal investigator, Centre hospitalo-universitaire de Nancy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06589232
- Sponsor's protocol ID
- 2024PI051
- Status last verified
- Apr 2024
- First submitted
- 10 Apr 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Threshold Dose Distribution for Pistachio Allergy in Children
- ClinicalTrials.gov ID
- NCT06589232
- Acronym / sponsor ID
- 2024PI051
- Conditions
- Allergy, Food Allergy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Apr 2024 (actual)
- Study completion
- 9 Apr 2024 (actual)
- First posted
- 19 Sep 2024 (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 main objective of this study is to describe the distribution of reactogenic thresholds for pistachio. The secondary objectives are to 1) describe the clinical severity of allergic reactions to pistachio in an oral challenge test, 2) compare the reactogenic thresholds of pistachio and cashew nut on matched data and 3) evaluate predictive factors of a low reactogenic threshold
Detailed description
Nuts, including almonds, walnuts, cashews, pistachio and hazelnut, are among the food allergens most frequently involved in food allergies in children with an estimated prevalence. between 0.05 and 4.9%.
According to data from the Allergo-Vigilance Network, peanuts and the group of nuts, led by cashews, are alone responsible for 51.4% of food anaphylaxis in children.
The pistachio belongs to the same botanical family as the cashew nut (Anacardiumouest) and the mango (Mangifera indica): the anacardiaceae. Botanically, pistachio and cashew are closely related and can both be responsible for moderate to severe immediate allergic reactions. Furthermore, in a previous publication by the team, co-sensitization to pistachio was observed in 98% of children allergic to cashew nuts with only 34% confirmed allergic to pistachio.
In the case of allergy to both anacardiaceae, in a small number of patients, the investigators reported a reactogenic threshold for pistachio greater than or equal to that for cashew nuts.
To our knowledge, there is currently only one study that has evaluated the reactogenic threshold for pistachio, compared to other nuts.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Food allergy | – | Other: Food allergyThreshold dose to pistachio |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Patients under 18 years of age who had a positive pistachio challenge test between January 2021 and December 2023, in the pediatric allergology unit of the Nancy CHRU
Key inclusion criteria (1 listed)
- Patients under 18 years of age who had a positive pistachio challenge test between January 2021 and December 2023, in the pediatric allergology unit of the Nancy CHRU.
Key exclusion criteria (2 listed)
- Patients who had a questionable oral pistachio provocation test.
- Patients who had a negative pistachio oral provocation test.
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 |
|---|---|---|
| Food allergyThreshold dose to pistachio | Other | Food allergy |
Primary outcome
Threshold dose to pistachio
Time frame: in the 4 hours of monitoring
in mg of protein
2 secondary outcomes
Threshold dose to cashew
Time frame: in the 4 hours of monitoring
Severity of the reaction during a positive pistachio oral provocation test
Time frame: in the 4 hours of monitoring
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
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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.
Amandine DIVARET-CHAUVEAU principal investigator
Centre hospitalo-universitaire de Nancy
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 Allergy and Food Allergy, 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 1 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: finished, as of the sponsor's last update on 19 Sep 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Threshold dose to pistachio (time frame: in the 4 hours of monitoring). 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 19 Sep 2024; AzTrials last refreshed its copy on 31 Oct 2026.