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Completed

NCT Number: NCT06589232

Threshold Dose Distribution for Pistachio Allergy

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

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Key information

Conditions

Allergy Food Allergy Food Hypersensitivity Hypersensitivity Hypersensitivity, Immediate Immune System Diseases

Age range

1 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Hospitalo-Universitaire de Nancy

Vandœuvre-lès-Nancy, France, 54511

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • Patients who had a questionable oral pistachio provocation test.
  • Patients who had a negative pistachio oral provocation test.

Treatment and study plan

Food allergy

Other

Threshold dose to pistachio

Primary outcomes

  1. Threshold dose to pistachio

    Time frame: in the 4 hours of monitoring

    in mg of protein

Secondary outcomes

  1. Threshold dose to cashew

    Time frame: in the 4 hours of monitoring

    in mg of proteins

  2. Severity of the reaction during a positive pistachio oral provocation test

    Time frame: in the 4 hours of monitoring

    defined by the COFAR (Consortium for Food Allergy Research) classification, from 1 to 5 and 1 is for mild symptoms

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Official study title

Threshold Dose Distribution for Pistachio Allergy in Children

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Sep 19, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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