Efficiency And Tolerance Of Hazelnut Oral Immunotherapy Protocol In Hazelnut Allergic Children

Completed

• Conditions: Pediatric ALL; Allergy, Nut
• Interventions: Other: Clinical and biological characteristics

• Registration Number: NCT04841850
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

Prevalence of food allergy in the world has been inscreasing in recent years. Among nut allergy, hazelnut allergy is the most widespread in Europe and particularly in France. The current treatment for hazelnut allergy is based on eviction and wearing of an emergency kit with adrenaline auto-injector pens, to be used in the event of severe anaphylactic reaction. Oral immunotherapy (OIT) is a treatment that is now increasingly being offered as an alternatice to eviction. There are few published data concerning hazelnut OIT in Europe, where its consumption is nevertheless very high.

The main objective of our study is to evaluate the clinical efficacy of the hazelnut OIT protocol, implemented since 2015 in the pneumology and allergology-paediatric department of the Mother and Child Hospital in Bron, in hazelnut allergic children under 18 years old.

The secondary objectives will be to evaluate the biological efficacy and clinical tolerance of the protocol.

The study is retrospective and observational, and is based on the collection of medical data from patient records.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2021-03
• Study Start: 2021-03-01
• Primary Completion: 2021-04-01
• Study First Submitted: 2021-04-08
• Study First Submitted QC: 2021-04-08
• Study First Posted: 2021-04-12
• Study Completion: 2021-05-15
• Last Update Submitted: 2021-09-10
• Last Update Posted: 2021-09-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• Aged Under eighteen years old
• Hazelnut allergy (clinically and biologically)
• Under IOT hazelnut protocol in Pneumo/allergology-paediatric departement of the Mother and Child hospital in Bron

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Exclusion Criteria

• Lack of consent to be included in the study (by their parents)
• Age > 18 years old

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Hazelnut allergic children under oral immunotherapy	Clinical and biological characteristics	* Children Under eighteen years of age * Convincing clinical history of hazelnut allergy * Positive hazelnut prick test or specific IgE * Under IOT hazelnut protocol in pneumology and allergology-paediatric departement of the Mother and Child Hospital in Bron

Primary Outcome Measures

Name	Time	Method
the proportion of patients in maintenance phase at the one-year consultation	at the one-year consultation	Patients are in maintenance phase at the end of the up-dosing phase and take regularly a quantity of hazelnut, usually superior to 800 mg, considered an acceptable protective dose

Trial Locations

Locations (1)

Pneumology allergology-paediatric department of the Mother and Child Hospital; 🇫🇷 Bron, France