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

NCT04841850 | Completed

• 1 other identifier: 186
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Allergy, Nut; Pediatric ALL

Keywords

Hazelnut; Oral Immunotherapy; Children; Protocol; Efficiency; Tolerance

Outcome Measures

Primary Outcomes (1)

• the proportion of patients in maintenance phase 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

  at the one-year consultation

Study Arms (1)

Hazelnut allergic children under oral immunotherapy

* 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

Other: Clinical and biological characteristics

Interventions

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

Hazelnut allergic children under oral immunotherapy

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Children aged under eighteen. With hazelnut allergy (convincing clinical history and positivity of hazelnut skin prick test history or specific IgE) Under IOT hazelnut protocol in Pneumology/allergology-paediatric department of the Mother and Child Hospital in Bron

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Pneumology allergology-paediatric department of the Mother and Child Hospital

Bron, 69500, France

Location

Related Publications (1)

• Sabouraud M, Bierme P, Andre-Gomez SA, Villard-Truc F, Payot F, Correard AK, Garnier L, Braun C. Real-life experience with hazelnut oral immunotherapy. Ann Allergy Asthma Immunol. 2022 Apr;128(4):432-438. doi: 10.1016/j.anai.2022.01.002. Epub 2022 Jan 8.

  PMID: 35007745 DERIVED

MeSH Terms

Conditions

Nut Hypersensitivity; Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Nut and Peanut Hypersensitivity; Food Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2021
• First Posted: April 12, 2021
• Study Start: March 1, 2021
• Primary Completion: April 1, 2021
• Study Completion: May 15, 2021
• Last Updated: September 17, 2021

Record last verified: 2021-03

Locations

FR (1)