TrialReader


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

NCT04841850 — Completed, 70 participants, Hospices Civils de Lyon

ClinicalTrials Daily  ·  Areas  ·  Conditions  ·  Drugs  ·  Sponsors  ·  

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

RegistryNCT04841850, acronym ENOIME
StatusCompleted
Study typeObservational
Enrollment70 (Actual)
SponsorHospices Civils de Lyon (Other)
ConditionsAllergy, Nut, Pediatric ALL
InterventionsClinical and biological characteristics (Other)
Datesstart 2021-03-01, primary completion 2021-04-01, completion 2021-05-15, first posted 2021-04-12, last updated 2021-09-17
Locations1 site in France

Related Papers Related Patents Related Grants Related Experts
AI Assistant Save
All trials for Allergy, Nut All trials for Pediatric ALL All trials of Clinical and biological characteristics

-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.

Expand all sections  ·  Collapse all

+Arms and interventions

ArmTypeInterventionsDescription
Hazelnut allergic children under oral immunotherapyOther: Clinical and biological characteristics* 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
  • 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

+Outcome measures

Primary outcomes

  • 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

Sex: All, ages: 1 Year to 18 Years

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

+Locations (1)

FacilityCityCountryStatus
Pneumology allergology-paediatric department of the Mother and Child HospitalBronFrance

+Publications

  • Results publication: 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

My Notes