UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000047699
Receipt number R000054302
Scientific Title Assessment of microbiome on mothers and offspring
Date of disclosure of the study information 2022/05/16
Last modified on 2022/05/10 14:10:04

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Basic information

Public title

Assessment of microbiome on mothers and offspring

Acronym

Assessment of microbiome on mothers and offspring

Scientific Title

Assessment of microbiome on mothers and offspring

Scientific Title:Acronym

Assessment of microbiome on mothers and offspring

Region

Japan


Condition

Condition

Healthy pregnant women and offspring

Classification by specialty

Obstetrics and Gynecology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the microbiota of mothers and infants and the association with pregnancy outcomes, allergic symptoms and gastrointestinal symptoms.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Gut microbiome
mothers: during pregnancy and after childbirth
infants: the first two years

Key secondary outcomes

vaginal microbiome
gastrointestinal symptoms
intestinal environment(pH, organic acid)
allergic of infant
mother:during pregnancy and after childbirth
infants: the first two years


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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Japanese pregnant women who are undergoing prenatal checkups at the National Center for Child Health and Development and are planning to have childbirth and postpartum checkup at this center

pregnant women who plan vaginal delivery
singleton pregnancy over 20 years old
with well-understanding and keeping the secret about this study

Key exclusion criteria

the pregnant women with fetal morphological abnormalities
pregnant women with hypertension, diabetes, autoimmune diseases, etc
pregnant women who will be treated with antibiotics at childbirth
pregnant women who participate the other study related with foods, medicines and cosmetics
pregnant women who are considered not available this study participation

Target sample size

40


Research contact person

Name of lead principal investigator

1st name Tomo Suzuki
Middle name
Last name Suzuki

Organization

National Center for Child Health and Development

Division name

Center for Maternal-Fetal, Neonatal and Reproductive Medicine

Zip code

157-8535

Address

2-10-1, Okura, Setagaya-ku, Tokyo, Japan

TEL

03-3416-0181

Email

suzuki-tm@ncchd.go.jp


Public contact

Name of contact person

1st name Tomo Suzuki
Middle name
Last name Suzuki

Organization

National Center for Child Health and Development

Division name

Center for Maternal-Fetal, Neonatal and Reproductive Medicine

Zip code

157-8535

Address

2-10-1, Okura, Setagaya-ku, Tokyo, Japan

TEL

03-3416-0181

Homepage URL


Email

suzuki-tm@ncchd.go.jp


Sponsor or person

Institute

National Center for Child Health and Development

Institute

Department

Personal name



Funding Source

Organization

Yakult Honsha Co.,Ltd

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

National Center for Child Health and Development

Address

2-10-1, Okura, Setagaya-ku, Tokyo, Japan

Tel

03-3416-0181

Email

suzuki-tm@ncchd.go.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



Other administrative information

Date of disclosure of the study information

2022 Year 05 Month 16 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

40

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

2021 Year 03 Month 09 Day

Date of IRB

2021 Year 03 Month 09 Day

Anticipated trial start date

2021 Year 03 Month 26 Day

Last follow-up date

2024 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

We are assessing about microbiota of mothers and infants


Management information

Registered date

2022 Year 05 Month 10 Day

Last modified on

2022 Year 05 Month 10 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054302


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name