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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000033400
Receipt No. R000037568
Scientific Title Birth Cohort Observational Study of Factors Associated with the Development of Infant Atopic Dermatitis
Date of disclosure of the study information 2018/09/01
Last modified on 2019/08/08

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Basic information
Public title Birth Cohort Observational Study of Factors Associated with the Development of Infant Atopic Dermatitis
Acronym Study of factors associated with the development of infantile atopic dermatitis
Scientific Title Birth Cohort Observational Study of Factors Associated with the Development of Infant Atopic Dermatitis
Scientific Title:Acronym Study of factors associated with the development of infantile atopic dermatitis
Region
Japan

Condition
Condition Atopic dermatitis
Classification by specialty
Pediatrics Dermatology Child
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 Barrier dysfunction associated with atopic dermatitis (AD) in the infancy is one of most important factors for food allergen sensitization and food allergy (FA). It was reported that some moisturizing agents reduced incidence of AD in infancy. However, its effect may not be sufficient. The aim of this study is to elucidate factors related with AD in infancy by comparing the children who develop AD and those who do not develop AD despite of cleaning and moisturization to keep barrier function from neonatal period until 12 months of age.
Transepidermal water loss, immunoactive substances in sera and breast milk, bacterial flora of skin, feces and saliva are examined at several time points from birth until 12 months of age.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes prevalence late of atopic dermatitis in 12 months
Key secondary outcomes (1)Allergen sensitisation
(2)Skin condition
(3)Saliva, skin, and fecal flora
(4)Immunoreactive substances in breast milk and sera

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 (1)Healthy full-term newborns
(2)Those who have agreed to participate in the study by their parents and guardians
Key exclusion criteria (1)Premature and low birth weight infants
(2)Infants scheduled for a recent relocation and not scheduled for an infant health checkup at the study site
(3)Infants with a family history of hereditary skin disorders (excluding ichthyosis vulgaris)
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Naoki Shimojo
Organization Graduate School of Medicine, Chiba University
Division name Department of pediatrics
Zip code
Address 1-8-1 Inohana, Chuo-ku, Chiba, JAPAN
TEL 043-226-2144
Email shimojo@faculty.chiba-u.jp

Public contact
Name of contact person
1st name
Middle name
Last name Naoki Shimojo
Organization Graduate School of Medicine, Chiba University
Division name Department of pediatrics
Zip code
Address 1-8-1 Inohana, Chuo-ku, Chiba, JAPAN
TEL 043-226-2144
Homepage URL
Email shimojo@faculty.chiba-u.jp

Sponsor
Institute Graduate School of Medicine, Chiba University
Institute
Department

Funding Source
Organization AMED
Chiba University
Miraka Co.Ltd
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor (1)Ichikawa clinic
(2)University of Michigan,Michigan Medicine
(3)Miraca Research Institute G.K.
(4)Nagoya University Graduate School of Medicine, Department of Dermatology
(5)Natural Science Co.,Ltd.
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 医療法人いちかわクリニック(福島県)

Other administrative information
Date of disclosure of the study information
2018 Year 09 Month 01 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 Open public recruiting
Date of protocol fixation
2018 Year 03 Month 23 Day
Date of IRB
2018 Year 03 Month 23 Day
Anticipated trial start date
2019 Year 02 Month 16 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information (1)Investigate the incidence of atopic dermatitis up to 12 months of age in infants whose skin care was done by washing and moisturizing, and compare past data (historical control).
(2)About the cohort of (1)above, development of AD, allergen sensitization, the bacterial flora of saliva/skin/stool, immunoactive substance in breast milk and sera will be evaluated.Based on these studies factors on the maternal side and infant side related to development of AD and sensitization will be found and used for future prevention of allergic diseases.

Management information
Registered date
2018 Year 07 Month 16 Day
Last modified on
2019 Year 08 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037568

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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