NCT03776474

Brief Summary

The study objectives are : Determine standards of plasma levels of casein-specific immunoglobulin G4 (IgG4) and egg-specific immunoglobulin G4 (IgG4) as a function of age, in non-allergic children, in allergic children, and in cured former allergic patients. Analyze the plasma IgG4 / IgE ratio, according to the result of the oral provocation test (tolerance versus allergy) and, in the event of a reaction, according to the reactogenic dose (dose which caused the reaction).Determine whether analysis of the plasma metabolome can identify children with a cured allergy to cow's milk protein or to egg from those with a persistent allergy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
135

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 6, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 14, 2018

Completed
1.9 years until next milestone

Study Start

First participant enrolled

November 17, 2020

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 19, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 19, 2023

Completed
Last Updated

April 16, 2026

Status Verified

April 1, 2026

Enrollment Period

2.8 years

First QC Date

December 6, 2018

Last Update Submit

April 13, 2026

Conditions

Food Allergy in Children

Keywords

Food allergy in childrenImmunoglobulin EImmunoglobulin G4Oral food challengePlasma metabolomic analysis

Outcome Measures

Primary Outcomes (1)

  • Plasma concentration of casein-specific immunoglobulin G4 and egg-specific immunoglobulin G4

    Day 0

Secondary Outcomes (7)

  • Plasma concentration of casein-specific immunoglobulin E and egg-specific immunoglobulin E

    Day 0

  • Total immunoglobulin E plasma concentration

    Day 0

  • Plasma concentration of casein-specific immunoglobulin G4 / plasma concentration of casein-specific immunoglobulin E ratio

    Day 0

  • Plasma concentration of egg-specific immunoglobulin G4 / plasma concentration of egg-specific immunoglobulin E ratio

    Day 0

  • Plasma concentration of casein-specific immunoglobulin G4 / total immunoglobulin E plasma concentration ratio

    Day 0

  • +2 more secondary outcomes

Study Arms (3)

Allergic

Minors allergic to cow's milk and/or eggs

Biological: Blood collection

Non-allergic

Minors without history of allergy to cow's milk and/or eggs

Biological: Blood collection

Acquired tolerance

Minors formerly allergic to cow's milk and/or eggs

Biological: Blood collection

Interventions

Blood collectionBIOLOGICAL

Patients less than 5 kg : 2 ml Patients over 5 kg : 3 ml Patients over 10 kg : 5 ml

Acquired toleranceAllergicNon-allergic

Eligibility Criteria

Age1 Month - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Minors in consultation or hospitalized at Necker Hospital

You may qualify if:

  • Minors aged 0 to 18
  • In consultation or hospitalized for an oral food challenge for milk or eggs
  • To undergo a blood test

You may not qualify if:

  • Minors with immune deficiency, chronic inflammatory disease or immunosuppressive or immunomodulator treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Necker Enfants malades

Paris, 75015, France

Location

Related Publications (1)

  • Adel-Patient K, Lezmi G, Castelli FA, Blanc S, Bernard H, Soulaines P, Dumond P, Ah-Leung S, Lageix F, de Boissieu D, Cortes-Perez N, Hazebrouck S, Fenaille F, Junot C, Dupont C. Deep analysis of immune response and metabolic signature in children with food protein induced enterocolitis to cow's milk. Clin Transl Allergy. 2018 Sep 28;8:38. doi: 10.1186/s13601-018-0224-9. eCollection 2018.

    PMID: 30275944BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Guillaume Lezmi, MD, PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 6, 2018

First Posted

December 14, 2018

Study Start

November 17, 2020

Primary Completion

September 19, 2023

Study Completion

September 19, 2023

Last Updated

April 16, 2026

Record last verified: 2026-04

Locations

FR(1)