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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04841850
Acronym
ENOIME
Enrollment
70
Registered
2021-04-12
Start date
2021-03-01
Completion date
2021-05-15
Last updated
2021-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allergy, Nut, Pediatric ALL

Keywords

Hazelnut, Oral Immunotherapy, Children, Protocol, Efficiency, Tolerance

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.

Interventions

OTHERClinical 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

Sponsors

Hospices Civils de Lyon
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Years to 18 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
the proportion of patients in maintenance phase at the one-year consultationat the one-year consultationPatients 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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 19, 2026