Observatory of the Lille Paediatric Allergy Unit

NCT06634992 | Recruiting

• 1 other identifier: RNIPH-2021-36
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to set up a paediatric observatory within the allergology department of The saint Vincent Hospital, Lille. The study aims to: • Collect exhaustive prospective data from patients eligible for oral immunotherapy. This prospective observatory will enable statistical analyses to be carried out on common food allergens such as hazelnut, cashew nut, pistachio and others.

Conditions

Child Allergy; IgE-Mediated Allergic Process; Food Allergy

Keywords

Food allergy; Food challenge test; IgE-Mediated; Observatory

Outcome Measures

Primary Outcomes (15)

• Age

  For each patient, and for each visit during the treatment period the collection of anthropometric, sociodemographic and medical data relating to oral food challenge will be done

  at inclusion

• Sex

  For each patient, and for each visit during the treatment period the collection of anthropometric, sociodemographic and medical data relating to oral food challenge will be done

  at inclusion

• Oral immunotherapies followed before inclusion

  For each patient, and for each visit during the treatment period the collection of anthropometric, sociodemographic and medical data relating to oral food challenge will be done

  at inclusion

• Determination of comorbidities

  For each patient, and for each visit during the treatment period the collection of anthropometric, sociodemographic and medical data relating to oral food challenge will be done

  at inclusion

• Determination of allergen under consideration

  For each patient, and for each visit during the treatment period the collection of anthropometric, sociodemographic and medical data relating to oral food challenge will be done

  at inclusion

• Specific IgE

  For each patient, and for each visit during the treatment period the collection of anthropometric, sociodemographic and medical data relating to oral food challenge will be done

  at inclusion

• Recombinants

  For each patient, and for each visit during the treatment period the collection of anthropometric, sociodemographic and medical data relating to oral food challenge will be done

  5 years

• Cumulative ingested dose

  This dose will be determined by mg/food and m/ food protein

  5 years

• Allergic reaction according to the Astier and Coll classification

  Astier score for anaphylaxis according to symptoms: 0- Absent 1- Abdominal pain spontaneous resolution, Urticaria \< 10 papules, Eczema, Rhinoconjunctivitis 2-1 Organ affected, Abdominal pain requiring treatment, Angioedema with laryngeal involvement, Moderate asthma: cough and PEF \> 20%. 3- 2 Affected organs 4- 3 organs affected or Asthma attack requiring treatment or Laryngeal edema or Arterial hypotension 5- Cardiorespiratory impairment requiring ICU admission

  5 years

• Type of oral challenge

  Type of ingested food during the oral immunotherapy: fresh food / industrial products

  5 years

• Reception of emergency kit

  If the reception of an emergency kit was needed will be determined by yes/no

  5 years

• Second oral food challenge

  If a second oral challenge was needed will be determined by yes/no

  5 years

• Tolerance according to reactogenic thresholds for allergens

  Subsequent visits will follow the patient's usual routine until the desensitisation threshold is reached or the patient decides to stop the oral immunotherapy protocol.

  5 years

• Amount of reactions IgE mediated

  Subsequent visits will follow the patient's usual routine until the desensitisation threshold is reached or the patient decides to stop the oral immunotherapy protocol.

  5 years

• Amount of reactions non IgE mediated

  Subsequent visits will follow the patient's usual routine until the desensitisation threshold is reached or the patient decides to stop the oral immunotherapy protocol.

  5 years

Study Arms (3)

Group 1

Allergy to hazelnut, walnut, pistachio, cashew or peanut

Other: Oral immunotherapy

Group 2

Allergy to cow's milk, wheat or egg

Other: Oral immunotherapy

Group 3

Allergy to unusual foods: sesame, celery, fenugreek, peas, lentils or others

Other: Oral immunotherapy

Interventions

Oral immunotherapy OTHER

Clinical Follow up

Group 1; Group 2; Group 3

Eligibility Criteria

• Age: Up to 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

All eligible patients consulting at the allergology service of the Saint Vincent Hospital, Lille, France will be informed and included, unless they object.

You may qualify if:

• patient under 15 years and 9 months,
• positive diagnosis of food allergy (positive food challenge test or "highly probable allergy", defined by a convincing history, a positive prick test and IgE \> 0.35 kUA/L),
• eligible for oral food challenge
• accepting the following allergens : hazelnut, walnut, pistachio, cashew, peanut, cow's milk, wheat, egg, sesame, celery, fenugreek, pea, lentils or others

You may not qualify if:

• Opposition
• Already received oral challenge for the same allergen.

Sponsors & Collaborators

• Lille Catholic University: lead

Study Sites (1)

Groupement de l'Institut Catholique de Lille - Hôpital Saint Vincent de Paul

Lille, 59000, France

RECRUITING

MeSH Terms

Conditions

Food Hypersensitivity

Interventions

Immunotherapy

Condition Hierarchy (Ancestors)

Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Immunomodulation; Biological Therapy; Therapeutics

Study Officials

• Tomas MORALY

  Groupement des Hopitaux de l'institut catholique de Lille

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Domitille Tristram

CONTACT

+ 33 3 20 22 57 37; tristram.domitille@ghicl.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2024
• First Posted: October 10, 2024
• Study Start: January 1, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: October 10, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)