Food Allergy in Children Clinical Trial
— IgG4Official title:
Determine Immunoglobulin G4 (IgG4) Standards for Cow's Milk and Egg in Different Populations of Allergic and Non-allergic Children
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.
Status | Recruiting |
Enrollment | 500 |
Est. completion date | November 18, 2023 |
Est. primary completion date | November 18, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 1 Month to 18 Years |
Eligibility | Inclusion Criteria: - Minors aged 0 to 18 - In consultation or hospitalized for an oral food challenge for milk or eggs - To undergo a blood test Exclusion Criteria: Minors with immune deficiency, chronic inflammatory disease or immunosuppressive or immunomodulator treatment |
Country | Name | City | State |
---|---|---|---|
France | Hôpital Necker Enfants malades | Paris |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique - Hôpitaux de Paris |
France,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Plasma concentration of casein-specific immunoglobulin G4 and egg-specific immunoglobulin G4 | Day 0 | ||
Secondary | Plasma concentration of casein-specific immunoglobulin E and egg-specific immunoglobulin E | Day 0 | ||
Secondary | Total immunoglobulin E plasma concentration | Day 0 | ||
Secondary | Plasma concentration of casein-specific immunoglobulin G4 / plasma concentration of casein-specific immunoglobulin E ratio | Day 0 | ||
Secondary | Plasma concentration of egg-specific immunoglobulin G4 / plasma concentration of egg-specific immunoglobulin E ratio | Day 0 | ||
Secondary | Plasma concentration of casein-specific immunoglobulin G4 / total immunoglobulin E plasma concentration ratio | Day 0 | ||
Secondary | Plasma concentration of egg-specific immunoglobulin G4 / total immunoglobulin E plasma concentration ratio | Day 0 | ||
Secondary | Plasma metabolomic analysis | Day 0 |
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