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Determine Immunoglobulin G4 (IgG4) Standards for Cow's Milk and Egg in Different Populations of Allergic and Non-allergic Children (IgG4)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03776474
Recruitment Status : Not yet recruiting
First Posted : December 14, 2018
Last Update Posted : January 9, 2020
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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.


Condition or disease Intervention/treatment
Food Allergy in Children Biological: Blood collection

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Determine Immunoglobulin G4 (IgG4) Standards for Cow's Milk and Egg in Different Populations of Allergic and Non-allergic Children
Estimated Study Start Date : January 2020
Estimated Primary Completion Date : January 2023
Estimated Study Completion Date : January 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

Group/Cohort Intervention/treatment
Allergic
Minors allergic to cow's milk and/or eggs
Biological: Blood collection
Patients less than 5 kg : 2 ml Patients over 5 kg : 3 ml Patients over 10 kg : 5 ml

Non-allergic
Minors without history of allergy to cow's milk and/or eggs
Biological: Blood collection
Patients less than 5 kg : 2 ml Patients over 5 kg : 3 ml Patients over 10 kg : 5 ml

Acquired tolerance
Minors formerly allergic to cow's milk and/or eggs
Biological: Blood collection
Patients less than 5 kg : 2 ml Patients over 5 kg : 3 ml Patients over 10 kg : 5 ml




Primary Outcome Measures :
  1. Plasma concentration of casein-specific immunoglobulin G4 and egg-specific immunoglobulin G4 [ Time Frame: Day 0 ]

Secondary Outcome Measures :
  1. Plasma concentration of casein-specific immunoglobulin E and egg-specific immunoglobulin E [ Time Frame: Day 0 ]
  2. Total immunoglobulin E plasma concentration [ Time Frame: Day 0 ]
  3. Plasma concentration of casein-specific immunoglobulin G4 / plasma concentration of casein-specific immunoglobulin E ratio [ Time Frame: Day 0 ]
  4. Plasma concentration of egg-specific immunoglobulin G4 / plasma concentration of egg-specific immunoglobulin E ratio [ Time Frame: Day 0 ]
  5. Plasma concentration of casein-specific immunoglobulin G4 / total immunoglobulin E plasma concentration ratio [ Time Frame: Day 0 ]
  6. Plasma concentration of egg-specific immunoglobulin G4 / total immunoglobulin E plasma concentration ratio [ Time Frame: Day 0 ]
  7. Plasma metabolomic analysis [ Time Frame: Day 0 ]

Biospecimen Retention:   Samples Without DNA
Serum


Information from the National Library of Medicine

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Ages Eligible for Study:   1 Month to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Minors in consultation or hospitalized at Necker Hospital
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03776474


Contacts
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Contact: Guillaume Lezmi, MD, PhD +33 1 44 49 48 38 guillaume.lezmi@aphp.fr
Contact: Hélène Morel +33 1 71 19 63 46 helene.morel@aphp.fr

Locations
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France
Hôpital Necker Enfants malades
Paris, France, 75015
Contact: Guillaume Lezmi, MD, PhD    +33 1 44 49 48 38    guillaume.lezmi@aphp.fr   
Contact: Hélène Morel    +33 1 71 19 63 46    helene.morel@aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Guillaume Lezmi, MD, PhD Assistance Publique - Hôpitaux de Paris
Publications:
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT03776474    
Other Study ID Numbers: APHP180057
2018-A01972-53 ( Registry Identifier: ID RCB )
First Posted: December 14, 2018    Key Record Dates
Last Update Posted: January 9, 2020
Last Verified: December 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Food allergy in children
Immunoglobulin E
Immunoglobulin G4
Oral food challenge
Plasma metabolomic analysis
Additional relevant MeSH terms:
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Food Hypersensitivity
Hypersensitivity
Immune System Diseases
Hypersensitivity, Immediate