ENOIME: Efficiency And Tolerance Of Hazelnut Oral Immunotherapy Protocol In Hazelnut Allergic Children
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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
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
|
Outcome Measures
Primary Outcome Measures
- 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
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Pneumology allergology-paediatric department of the Mother and Child Hospital | Bron | France | 69500 |
Sponsors and Collaborators
- Hospices Civils de Lyon
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 186