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

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.

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Key information

Conditions

Allergy, Nut Food Hypersensitivity Hematologic Diseases Hemic and Lymphatic Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Nut Hypersensitivity Nut and Peanut Hypersensitivity Pediatric ALL Precursor Cell Lymphoblastic Leukemia-Lymphoma

Age range

1 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Pneumology allergology-paediatric department of the Mother and Child Hospital

Bron, 69500, France

Who can participate

Healthy volunteers accepted: No

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

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

Exclusion criteria

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

Treatment and study plan

Clinical and biological characteristics

Other

Age at beginning of IOT
Sex
Atopic and non atopic Comorbidities
Sensitization to aero-allergens
Sensitization to trophallergens
Stage of severity of the elicited reaction
Hazelnut Specific IgE + Cor a 1,8,9,14 before IOT and during follow up
Hazelnut skin prick test before IOT and during follow up
Adverse effects of IOT and their stage (in hospital and at home)
Use of adrenaline auto-injector (in hospital and at home)
Maintenance dose

Primary outcomes

the proportion of patients in maintenance phase at the one-year consultation

Time frame: 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

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

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

Acronym: ENOIME

Important dates

Study start: 2021
Primary completion: 2021
Study completion: 2021
First posted: Apr 12, 2021
Registry last updated: Sep 17, 2021

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.

Published trials that share one or more normalized conditions with this study.

Completed