UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062644 |
|---|---|
| Receipt number | R000071705 |
| Scientific Title | A birth cohort observational study of skin factors associated with the development of infantile atopic dermatitis |
| Date of disclosure of the study information | 2026/08/21 |
| Last modified on | 2026/08/21 11:09:39 |
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Basic information
Public title
A birth cohort observational study of skin factors associated with the development of infantile atopic dermatitis
Acronym
Osaka Birth Cohort
Scientific Title
A birth cohort observational study of skin factors associated with the development of infantile atopic dermatitis
Scientific Title:Acronym
Osaka Birth Cohort
Region
| Japan |
Condition
Condition
Infantile atopic dermatitis and food allergy
Classification by specialty
| Clinical immunology | Obstetrics and Gynecology | Pediatrics |
| Dermatology | Child |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To longitudinally assess skin manifestations, skin barrier function, skin microbiota, skin lipids, allergen sensitization, vitamin D, and other immune-related markers from birth to 12 months of age; to identify maternal, infant, and environmental factors associated with the development of atopic dermatitis and food allergy; and to explore targets for prevention.
Basic objectives2
Others
Basic objectives -Others
Exploration of etiologic and preventive factors
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Incidence of atopic dermatitis at 6 and 12 months of age
Key secondary outcomes
Food allergen sensitization rate at 6 and 12 months of age; transepidermal water loss (TEWL), stratum corneum water content (SCWC), skin pH, skin microbiota, and skin lipids (ceramides and fatty acids) at each postnatal assessment
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
[Pregnant women] 1) Continuation of antenatal care and planned delivery and postpartum checkups at a participating institution; 2) age 20 to <45 years at consent; 3) <36 weeks of gestation at consent; 4) written informed consent after adequate explanation; and 5) planned use of the standard skin-care regimen of the institution. [Infants] Full-term infants whose legally authorized representatives provide written informed consent after adequate explanation.
Key exclusion criteria
1) Withdrawal of consent; 2) preterm birth or birth weight <2,500 g; 3) admission of the infant to a neonatal intensive care unit; or 4) any other condition judged by the investigator to make participation inappropriate.
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Yasuji |
| Middle name | |
| Last name | Kitabatake |
Organization
Graduate School of Medicine, The University of Osaka
Division name
Department of Pediatrics
Zip code
565-0871
Address
2-2 Yamadaoka, Suita, Osaka 565-0871, Japan
TEL
06-6879-3932
jimu@ped.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Yumi |
| Middle name | |
| Last name | Matsuoka |
Organization
Immunology Frontier Research Center, The University of Osaka
Division name
Cutaneous Allergy and Host Defense
Zip code
565-0871
Address
3-1 Yamadaoka, Suita, Osaka 565-0871, Japan
TEL
06-6879-4963
Homepage URL
https://www.ifrec.osaka-u.ac.jp/jpn/laboratory/yumi_matsuoka/index.htm
ymatsuoka@derma.med.osaka-u.ac.jp
Sponsor or person
Institute
The University of Osaka
Institute
Department
Personal name
Funding Source
Organization
The University of Osaka
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Immunology Frontier Research Center, The University of Osaka; National Hospital Organization Osaka Minami Medical Center; Osaka Habikino Medical Center; Yao Municipal Hospital
Name of secondary funder(s)
Japan Agency for Medical Research and Development (analysis funding); Natural Science Co., Ltd. (in-kind research materials)
IRB Contact (For public release)
Organization
The University of Osaka Hospital Observational Research Ethics Review Committee
Address
4F, Medical Innovation Center, 2-2 Yamadaoka, Suita, Osaka 565-0871, Japan
Tel
06-6210-8296
rinri@hp-crc.med.osaka-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
地方独立行政法人大阪府立病院機構大阪はびきの医療センター（大阪府）、八尾市立病院（大阪府）、独立行政法人国立病院機構大阪南医療センター（大阪府）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 08 | Month | 21 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2025 | Year | 10 | Month | 15 | Day |
Date of IRB
| 2026 | Year | 02 | Month | 17 | Day |
Anticipated trial start date
| 2026 | Year | 02 | Month | 18 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a multicenter birth cohort observational study. Pregnant women are enrolled at participating institutions, and infants are followed from birth to 12 months of age with longitudinal collection of skin findings, skin barrier function, skin microbiota, skin lipids, hematologic and immunologic markers, and the use of skin-care products. Routine skin care at each institution is neither assigned nor modified, and associations between its amount and frequency of use and outcomes related to atopic dermatitis and food allergy are analyzed.
Management information
Registered date
| 2026 | Year | 08 | Month | 21 | Day |
Last modified on
| 2026 | Year | 08 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071705
