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

Pediatric ALL Clinical Trial

— ENOIME  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04841850
• Other study ID #: 186
• Status: Completed
• Start date: March 1, 2021
• Est. completion date: May 15, 2021

Study information

• Verified date: March 2021
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: May 15, 2021
• Est. primary completion date: April 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Allergy, Nut
• Nut Hypersensitivity
• Pediatric ALL

Intervention

Other:
• Clinical and biological characteristics
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

Locations

Country	Name	City	State
France	Pneumology allergology-paediatric department of the Mother and Child Hospital	Bron

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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