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CompletedNCT04841850ENOIMEUpdated Sep 17, 2021

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

An observational study in Allergy, Nut and Pediatric ALL, sponsored by Hospices Civils de Lyon. Completed at 1 site in France. Open to participants aged 1 Year to 18 Years. Per ClinicalTrials.gov, last updated 2021-09-17.

Sponsored by Hospices Civils de Lyon · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
70
Ages
1 Year to 18 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Allergy, Nut
  • Pediatric ALL

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Keywords

  • Hazelnut
  • Oral Immunotherapy
  • Children
  • Protocol
  • Efficiency
  • Tolerance
03

Who can participate

Ages eligible
1 Year to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No
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

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

Exclusion Criteria:

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

Observational model
Cohort
Time perspective
Retrospective
Enrollment
70 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • 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

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What researchers measure

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

    Time frame: at the one-year consultation

06

Study locations

1 site
  • Pneumology allergology-paediatric department of the Mother and Child Hospital
    Bron, 69500, France
07

References and documents

Publications

  • 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. PubMed 35007745 ↗
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Registry details

Key details

Study ID
NCT04841850
Lead sponsor
Hospices Civils de Lyon
Responsible party
Sponsor
First posted
Apr 12, 2021
Start date
Mar 1, 2021
Primary completion
Apr 1, 2021
Completion
May 15, 2021
Last update
Sep 17, 2021

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.

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