Accidental Reactions in Peanut/Tree Nut Allergic Children (ALLERGY)

January 2, 2023 updated by: University Hospital, Lille

Accidental Reactions in a French Cohort of Children With Peanut and/or Tree Nut Allergy.

Food allergy is an immune reaction, triggered by food protein allergens, of varying severity, from mild local reaction to life threatening anaphylaxis and fatalities.

Peanut is a plant from the botanical family of the Fabaceae, more commonly known as legumes. The prevalence of peanut and tree nut allergy is increasing. In France (ELFE cohort), it is estimated to 0.93%. The tree nuts include mainly almond, hazelnut, pistachio, cashew nut, walnut, pecan nut and Brazil nut. Allergy's prevalence is estimated to 0.54% in children up to 5.5 years. Peanut allergy is a main cause of anaphylaxis and deaths due to food allergy.

Recurrence of food allergy is a main concern. The risk has been estimated to 10% per year for peanut.

In France, Data in real-life on the rate of recurrence of allergic reactions and anaphylaxis to peanut/tree-nut as well as risk factors, are lacking.

The objective of this study is to assess the frequency of allergic reaction to peanut and tree-nuts, to describe the reactions' characteristics and risk factors.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Lille, France
        • Recruiting
        • Hop Jeanne de Flandre Chu Lille

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients followed in the Pediatric Allergy and Pulmonology Unit, CHU Lille, aged 0-18 years with peanut and/or tree nut allergy

Description

Inclusion Criteria:

  • Confirmed allergy to peanuts and/or nuts

Exclusion Criteria:

  • Other chronic diseases, except allergic comorbidities (asthma, rhinitis, atopic dermatitis, other food allergy)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Allergic Children
Patients followed in the Pediatric Allergy and Pulmonology Unit, CHU Lille, aged 0-18 years with peanut and/or tree nut allergy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
the number of episode of allergic reactions in real life
Time Frame: At 1 year
At 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the severity of the allergic reactions according to a validated scale (FASS scale)
Time Frame: At 1 year
At 1 year
interview for the characteristics of the allergic reactions
Time Frame: At 1 year
the characteristics of the reactions: symptoms, triggering food and quantity, location, emergency kit available, treatment administered, evolution (hospitalization or emergency room)
At 1 year
interview to defined the risks factor associated
Time Frame: At 1 year

risk factors for reaction:

  • Other known allergies
  • Asthma
  • Atopic dermatitis
  • Allergic rhinoconjunctivitis
  • Patient characteristics: sex, age
At 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Lille

Investigators

  • Principal Investigator: Antoine DESCHILDRE, MD,PhD, University Hospital, Lille

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 22, 2021

Primary Completion (Anticipated)

September 1, 2023

Study Completion (Anticipated)

September 1, 2023

Study Registration Dates

First Submitted

November 3, 2022

First Submitted That Met QC Criteria

January 2, 2023

First Posted (Estimate)

January 4, 2023

Study Record Updates

Last Update Posted (Estimate)

January 4, 2023

Last Update Submitted That Met QC Criteria

January 2, 2023

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021/0099
  • 2021-A00746-35 (Other Identifier: ID-RCB number,ANSM)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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