Unique ID issued by UMIN | UMIN000029742 |
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Receipt number | R000033945 |
Scientific Title | Validation of novel biomarkers for treatment response to rush oral immunotherapy for food allergy in children |
Date of disclosure of the study information | 2017/10/28 |
Last modified on | 2017/10/31 12:18:00 |
Validation of novel biomarkers for treatment response to rush oral immunotherapy for food allergy in children
Immunoglobulin Maturation and Affinity Kinetics in Immunotherapy for Food Allergy (IMAKIFA) Study
Validation of novel biomarkers for treatment response to rush oral immunotherapy for food allergy in children
Immunoglobulin Maturation and Affinity Kinetics in Immunotherapy for Food Allergy (IMAKIFA) Study
Japan |
Food allergy
Clinical immunology | Pediatrics |
Others
NO
To test whether changes in serum levels and antigen affinity of allergen-specific IgE and IgG subclasses reflect treatment response to oral immunotheapy for food allergy
Bio-availability
Exploratory
Explanatory
Not applicable
Association of serum levels of allergen-specific IgE, IgG1, IgG2, IgG3, IgG4 and IgA(measured by highly sensitive DLC/DCP chip assay), antigen affinity of IgE and IgG1 (by competition binding assay using DLC/DCP chip) and desensitization levels (tolerable amount of food) induced by oral immunotherapy
Association of other immonological markers (basophil activation, urinary prostaglandin etc) and desensitization levels (tolerable amount of food) induced by oral immunotherapy
Observational
5 | years-old | <= |
20 | years-old | > |
Male and Female
Patients with food allergy who undergo rush oral immunotherapy
1.patients with any chronic disease other than allergic diseases
2.patients with uncontrolled asthma or atopic dermatitis
30
1st name | |
Middle name | |
Last name | Takao Fujisawa |
Mie National Hospital
Department of Clinical Research
357 Ozato- Kubota, Tsu, Mie, Japan
059-232-2531
eosinophilosophy@gmail.com
1st name | |
Middle name | |
Last name | Ryo Imakiire |
Mie National Hospital
Department of Pediatrics
357 Ozato- Kubota, Tsu, Mie, Japan
059-232-2531
iamluckymanjp@yahoo.co.jp
Department of Clinical Research, Mie National Hospital
Japan Agency for Medical Research and Development
Japanese Governmental office
NO
国立病院機構三重病院(三重県)、徳島大学先端酵素学研究所(徳島県)
2017 | Year | 10 | Month | 28 | Day |
Unpublished
Enrolling by invitation
2017 | Year | 10 | Month | 17 | Day |
2017 | Year | 10 | Month | 28 | Day |
2020 | Year | 02 | Month | 28 | Day |
2020 | Year | 03 | Month | 15 | Day |
2020 | Year | 03 | Month | 31 | Day |
2020 | Year | 04 | Month | 30 | Day |
Subjects: patients with food allergy who undergo oral immunotherapy (OIT)
Blood sampling: before OIT, at 1 week and 2 weeks during dose-escalation phase, at completion of dose-escalation phase(=start of maintenance phase), at 3mo, 6mo and 12mo during maintenance phase
Treatment outcome: amount of allergen food achieved at completion of dose-escalation phase and at 12mo in maintenance phase
Adverse events: induced allergic symptoms by OIT, severity of the symptoms
2017 | Year | 10 | Month | 27 | Day |
2017 | Year | 10 | Month | 31 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033945
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