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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04304586
Other study ID # RECHMPL20_0151
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2006
Est. completion date June 1, 2020

Study information

Verified date June 2020
Source University Hospital, Montpellier
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The prevalence of food allergies has increased in recent decades, ranging from 1 to 3% of the general population. According to international literature and French national surveys, nuts today represent a group of allergens often associated with severe allergic reactions. They are responsible for 18 to 40% of deaths from food-related anaphylaxis.

Among all nuts, the prevalence of anacardiac allergies (mainly cashew and pistachio) continues to increase and has become a growing public health problem. Today, global production is estimated at 4.9 million tonnes of cashews and 1.1 million tonnes of pistachios. The resulting increased exposure may explain the increased prevalence of allergic reactions reported to these fruits. In addition, anaphylactic reactions to anacardiaceae are reported to be even more severe than those occurring in subjects allergic to peanuts.

Cashews and pistachios are known to exhibit immunological cross-reactions with one another. In fact, they have a strong sequential homology between their storage allergens Ana o 1 / Pis v 3 (7S vicilin, 78% homology); Ana o 2 / Pis v 2 (legume 11S, 80% homology) and Ana o 3 / Pis v 1 (albumin 2S, 70% homology). For this reason, some authors talk about the cashew / pistachio syndrome and associate the two allergenic sources by considering them as one, in clinical practice.

The diagnosis of allergy to nuts, and therefore to anacardiaceae, is based on a compatible clinical history, the presence of specific IgE (demonstrated by positivity to realistic skin tests and serum IgE assay), and positivity on the oral food challenge test.

In clinical practice, taking into account the cashew / pistachio syndrome, when the allergy work-up for cashew is negative, allergists tend to advise to reintroduce pistachio at home, considering the two allergens as sufficiently homologous to authorize such a practice. In this context, the investigators decided to check whether this practice, which is based mainly on in vitro homologies, is risk-free, based on the clinical experience of our center.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date June 1, 2020
Est. primary completion date May 1, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion criteria:

- Patient evaluated at the Allergy Unit of the University Hospital of Montpellier (France)

- Suspicion of food allergy to Anacardiaceae

- Allergy work-up for cashew and pistachio including at least skin tests, and possible specific IgE and food challenge

Exclusion criteria:

- Patients included in other trials that don't allow them to be included in the present one

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
France Uhmontpellier Montpellier

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary PPV and NPV PPV and NPV of the results of skin tests and food challenge to either cashew or pistachio to predict a concordant result for pistachio or cashew, respectively 1 day
Secondary Relative risk Finding risk factors predictive of discrepancies between the results of the allergy work-up for cashew and pistachio 1 day