UMIN-CTR Clinical Trial

Public title

Investigating biomarkers for development of atopic dermatitis in early childhood using maternal-infant hair-related microRNA

Acronym

Hair-related microRNA effects by fetal tobacco smoke exposure on the development of subsequent infantile eczema

Scientific Title

Investigating biomarkers for development of atopic dermatitis in early childhood using maternal-infant hair-related microRNA

Scientific Title:Acronym

Hair-related microRNA effects by fetal tobacco smoke exposure on the development of subsequent infantile eczema

Region

Japan	North America	Australia

Condition

Eczema

Classification by specialty

Clinical immunology	Pediatrics	Dermatology
Child

Classification by malignancy

Others

Genomic information

YES

Narrative objectives1

In a high-risk birth cohort in pregnant mothers with eczema, we clarify transgenereationalmechanisum of fetal tobacco smoke exposure effects on the development of eczema using hair-related microRNA (miRNA).

Basic objectives2

Others

Basic objectives -Others

Using hair-related miRNA as a biomarker for the development of eczema.

Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable

Primary outcomes

Exploration of transgenerational hair-related miRNA

Key secondary outcomes

kinds of hair-related miRNA

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

Age-lower limit

18

years-old

<=

Age-upper limit

35

years-old

>

Gender

Male and Female

Key inclusion criteria

*Pregnant women (>= 28 gestation weeks)
*Pregnant mother and father with allergic diseases
*Pregnant mother and father without allergic diseases

Key exclusion criteria

*Pregnant mother with using medication
*Pregnant mother and father with chronic diseases, expect allergic diseases
*Pregnant mother who do not want avoid smoking
*Infants who born by cesarean section
*Premature infants
*Infants with with chronic diseases, expect allergic diseases
*Invidivuals with using supplements including vitamine
*Individuales with judgement of ineligible by a responsible researcher

Target sample size

500

Name of lead principal investigator

1st name	Miwa
Middle name
Last name	Shinohara

Organization

Juntendo University, Faculty of Medicine

Division name

Department of Pediatrics

Zip code

113-0033

Address

Department of Pediatrics

TEL

03-3813-3111

Email

mi-shinohara@juntendo.ac.jp

Name of contact person

1st name	Miwa
Middle name
Last name	Shinohara

Organization

Juntendo University, Faculty of Medicine

Division name

Department of Pediatrics

Zip code

113-0033

Address

3-1-3 Hongo, Bunkyo-ku TOKYO, 113-0033, JAPAN

TEL

03-3813-3111

Homepage URL

Email

mi-shinohara@juntendo.ac.jp

Institute

Departments of Pediatrics
Juntendo University, Faculty of Medicine
3-1-3 Hongo, Bunkyo-ku
TOKYO, 113-0033, JAPAN
TEL +81-3-3813-3111
FAX +81-3-5800-1580

Institute

Department

Personal name

Organization

Grants-in-Aid for Scientific Research (KAKENHI)
Kojimachi Business Center Building,
5-3-1 Kojimachi, Chiyoda-ku,
Tokyo 102-0083

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Co-sponsor

Department of Allergy and Clinical Immunology, National Research Institute for Child Health and Development, Tokyo; Dr. Kenji Matsumoto
The University of Western Australia, Faculty of Health and Medical Sciences, Perth Children's Hospital, Telethon Kids Institute, Australia; Professor. Susan Prescott
Perth Children's Hospital, Telethon Kids Institute. Research psychologist with the ORIGINS Project, Australia; Dr. Lisa Gibson
Department of Allergy, Tokyo Metropolitan Children's Medical Center, Tokyo; Dr. Masami Narita
Department of Epidemiology and Preventive Medicine, Graduate School of Medicine, Ehime University, Ehime; Dr. Keiko Tanaka
Okayama Saiseikai General Hospital Department of Pediatrics, Section Head, Dr. Testuro Kitamura

Name of secondary funder(s)

Organization

Departments of Pediatrics Juntendo University, Faculty of Medicine

Address

3-1-3 Hongo, Bunkyo-ku TOKYO, 113-0033, JAPAN

Tel

03-3813-3111

Email

mi-shinohara@juntendo.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

順天堂大学医学部　小児科学講座

Date of disclosure of the study information

2017

Year

06

Month

20

Day

URL releasing protocol

http://allergyimmunology.sx3.jp/

Publication of results

Unpublished

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

Recruitment status

Enrolling by invitation

Date of protocol fixation

2015

Year

12

Month

01

Day

Date of IRB

2018

Year

08

Month

06

Day

Anticipated trial start date

2018

Year

10

Month

10

Day

Last follow-up date

2023

Year

04

Month

05

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Open the entry HP
Hair MiRNA KAKEN HP
http://allergyimmunology.sx3.jp/

Registered date

2017

Year

06

Month

20

Day

Last modified on

2022

Year

12

Month

26

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031889