Unique ID issued by UMIN | UMIN000048496 |
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Receipt number | R000055265 |
Scientific Title | Study of food allergen sensitization in infancy utilizing allergen components (prospective study) |
Date of disclosure of the study information | 2022/07/28 |
Last modified on | 2023/01/26 11:55:38 |
Study of food allergen sensitization in infancy utilizing allergen components (prospective study)
Studies utilizing allergen components for infants (prospective studies)
Study of food allergen sensitization in infancy utilizing allergen components (prospective study)
Studies utilizing allergen components for infants (prospective studies)
Japan |
Food allergy
Pediatrics |
Others
NO
The objective is to clarify the clinical picture of food allergy in diverse infants and young children by latent class analysis utilizing allergen components.
Safety,Efficacy
Percentage of IgE-mediated food allergies in each cluster
Change in allergen component IgE antibody levels at 6, 12, and 18 months for each cluster,percentage of foods causing allergic reactions in each cluster, percentage of anaphylaxis in each cluster, percentage of each cluster acquiring tolerance to food allergy
Observational
4 | months-old | <= |
8 | months-old | >= |
Male and Female
Patients whose blood tests show sensitization to one or more food allergens (specific IgE level of 0.35 kUA/L or higher)
Patients deemed inappropriate as research subjects by the principal investigator
250
1st name | Sakura |
Middle name | |
Last name | Sato |
National Hospital Organization Sagamihara Hospital
Clinical Research Center
252-0392
18-1 Sakuradai, Minami-ku, Sagamihara, Kanagawa, Japan
0427428311
ssakura8010@foodallergy.jp
1st name | Yu |
Middle name | |
Last name | Ito |
National Hospital Organization Sagamihara Hospital
Paediatrics
252-0392
18-1 Sakuradai, Minami-ku, Sagamihara, Kanagawa, Japan
0427428311
yuito5156@gmail.com
National Hospital Organization Sagamihara Hospital
Nippon Ham Foundation for the Future of Food
Non profit foundation
Sagamihara Hospital Ethics Committee of the National Hospital Organization
18-1 Sakuradai, Minami-ku, Sagamihara, Kanagawa, Japan
0427428311
makino.megumi.bn@mail.hosp.go.jp
NO
2022 | Year | 07 | Month | 28 | Day |
Unpublished
Preinitiation
2022 | Year | 06 | Month | 29 | Day |
2022 | Year | 08 | Month | 01 | Day |
2025 | Year | 03 | Month | 31 | Day |
Research and Survey Items
<Research Items>
The following clinical information on the research subjects will be obtained from their medical records.
Background factors: gender, date of birth, nutritional methods, family history, presence/severity of atopic dermatitis, presence/absence of bronchial asthma, etc.
Blood tests: blood count, total IgE, allergen-specific IgE, allergen component-specific IgE, TARC
Blood test: 4-8 months, 10-14 months, 16-20 months of age IgE-mediated food allergy
Allergy: 4-8 months, 10-14 months, 16-20 months of age
<Specific IgE antibody titer measurement method Collect 2ml of blood sample for this study.
Specific IgE antibody titer measurement of crude antigen
Serum samples will be sent to RIKEN, and 41 allergens will be measured using Drop Screen A-1 (Nippon Chemiphar Co., Ltd.). The main allergens measured are raspberry, milk, wheat, mite, cedar, etc.
Specific IgE antibody titer measurement of allergen components
ImmunoCAP ISAC (Thermo Fisher Diagnostics) is used to measure 112 allergen components. The test items include egg white (Gal d 1, 2, 3, 4, 5), wheat (Tri a 14, Tri a 19), soybean (Gly m 4, 5, 6), peanut (Ara h 1, 2, 3, 6, 8, 9), etc.
<Evaluation Methods>
The collected data will be used to cluster the cases using the profile at 1 year of age.
2022 | Year | 07 | Month | 28 | Day |
2023 | Year | 01 | Month | 26 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055265
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