Efficiency And Tolerance Of Hazelnut Oral Immunotherapy Protocol In Hazelnut Allergic Children (ENOIME)

September 10, 2021 updated by: Hospices Civils de Lyon

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

70

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the proportion of patients in maintenance phase at the one-year consultation
Time Frame: 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
at the one-year consultation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 1, 2021

Primary Completion (ACTUAL)

April 1, 2021

Study Completion (ACTUAL)

May 15, 2021

Study Registration Dates

First Submitted

April 8, 2021

First Submitted That Met QC Criteria

April 8, 2021

First Posted (ACTUAL)

April 12, 2021

Study Record Updates

Last Update Posted (ACTUAL)

September 17, 2021

Last Update Submitted That Met QC Criteria

September 10, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 186

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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