UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000033400
Receipt number 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 2021/01/16 02:34:28

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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 or person

Institute

Graduate School of Medicine, Chiba University

Institute

Department

Personal name



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

No longer 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 12 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

2021 Year 01 Month 16 Day



Link to view the page

Value
https://center6.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