ENOIME
Clinic And Biologic Efficiency And Tolerance Of Oral Immunotherapy Protocol In Hazelnut Allergic Children
Sponsor study identifier
observational
70
1 country
1
Study Start
March 1, 2021
Actual (reported)Primary Completion
April 1, 2021
Actual (reported)Study Completion
May 15, 2021
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 15, 2021
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 1, 2021
Actual (reported)April 1, 2021
Actual (reported)April 8, 2021
Actual (reported)April 12, 2021
Actual (reported)May 15, 2021
Actual (reported)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
at the one-year consultation
* 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
* 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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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
Pneumology allergology-paediatric department of the Mother and Child Hospital
Bron, 69500, France
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.
70 participants (actual enrollment reported by the registry).
First Submitted
April 8, 2021
First Posted
April 12, 2021
Study Start
March 1, 2021
Actual (reported)Investigation of Remimazolam in Children Undergoing Sedation for Medical Procedures
Validation of the ANI in Perpubescent Patients in Pediatric Intensive Care Unit.
Contact the study team to confirm eligibility.
Primary Completion
April 1, 2021
Actual (reported)Study Completion
May 15, 2021
Actual (reported)Last Updated
September 17, 2021
Record last verified: 2021-03
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Source: ClinicalTrials.gov.
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