UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000043094
Receipt number R000047864
Scientific Title Evaluation of the intestinal environment for pregnant women and infants
Date of disclosure of the study information 2021/01/22
Last modified on 2021/01/22 17:23:19

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Basic information

Public title

Evaluation of the intestinal environment for pregnant women and infants

Acronym

Evaluation of the intestinal environment for pregnant women and infants

Scientific Title

Evaluation of the intestinal environment for pregnant women and infants

Scientific Title:Acronym

Evaluation of the intestinal environment for pregnant women and infants

Region

Japan


Condition

Condition

Healthy pregnant women

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the effects for allergic diseases in children by intestinal environment of pregnant women.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Intestinal microbiome and intestinal metabolome

Key secondary outcomes

Child atopy and eczema incidence rate (48 weeks old)


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

40 years-old >

Gender

Female

Key inclusion criteria

(1) Healthy pregnant women aged more than or equal to 20 and less than 40 years old.
(2) Subjects who show understanding of the study procedures and agreement with participating the study by written informed consent prior to the study.

Key exclusion criteria

(1) Subjects who are currently receiving medication.
(2) Subjects who are diagnosed with gestational diabetes or gestational hypertension.
(3) Subjects who have consumed medicines which affect the intestinal environment within the last 1 month to the observation start.
(4) Subjects who have current medical history/anamnesis of severe cardiac, hepatic, renal or digestive diseases.
(5) Subjects who are heavy use of alcohol.
(6) Smokers.
(7) Subjects who have extremely irregular dietary habits,working hours or daily rhythms.
(8) Subjects who are currently participating, or who have participated in other study for medicine or food within the last 4 weeks of the present study, or who possibly participate in another clinical trial after agreement of this study.
(9) Subjects who have been determined ineligible by principal investigator or sub-investigator.

Target sample size

30


Research contact person

Name of lead principal investigator

1st name Yoshihiro
Middle name
Last name Ide

Organization

Nihonkai General Hospital

Division name

obstetrics and gynecology

Zip code

998-8501

Address

30 Akiho-cho, Sakata, Yamagata

TEL

+81234262001

Email

research@metagen.co.jp


Public contact

Name of contact person

1st name Yumiko
Middle name
Last name Ichimura

Organization

Nihonkai General Hospital

Division name

Medical support department

Zip code

998-8501

Address

30 Akiho-cho, Sakata, Yamagata

TEL

+81234262001

Homepage URL


Email

research@metagen.co.jp


Sponsor or person

Institute

Metabologenomics, Inc.

Institute

Department

Personal name



Funding Source

Organization

METI(Japan)

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor

Nihonkai General Hospital

Name of secondary funder(s)

Metabologenomics, Inc.


IRB Contact (For public release)

Organization

Yamagata Sakata Hospital Organization Ethical Review Board

Address

30 Akiho-cho, Sakata, Yamagata

Tel

+81234262001

Email

research@metagen.co.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

日本海総合病院(山形県)


Other administrative information

Date of disclosure of the study information

2021 Year 01 Month 22 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

2020 Year 11 Month 30 Day

Date of IRB

2020 Year 11 Month 30 Day

Anticipated trial start date

2021 Year 01 Month 22 Day

Last follow-up date

2023 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Pregnant women who visit Nihonkai General Hospital after 22/01/2021 and who meet the inclusion criteria are selected for candidate of this study.


Management information

Registered date

2021 Year 01 Month 22 Day

Last modified on

2021 Year 01 Month 22 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047864


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name