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

NCT ID: NCT04841850

Last Updated: 2021-09-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

70 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-01

Study Completion Date

2021-05-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Allergy, Nut Pediatric ALL

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Clinical and biological characteristics

Intervention Type 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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

1 Year

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Pneumology allergology-paediatric department of the Mother and Child Hospital

Bron, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 35007745 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

186

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Peanut and Tree Nut Desensitization
NCT03532360 ACTIVE_NOT_RECRUITING NA
Walnut Oral Immunotherapy for Tree Nut Allergy
NCT01546753 COMPLETED PHASE1/PHASE2
Walnut Oral Immunotherapy for Tree Nut Allergy
NCT01834352 WITHDRAWN PHASE1/PHASE2
Oral Immunotherapy for Peanut Allergic Patients
NCT04163562 RECRUITING PHASE1/PHASE2