UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000045125
Receipt number R000046509
Scientific Title Investigation of the interrelation among mental, physical and gut microbiota in the postpartum mother and infants
Date of disclosure of the study information 2021/08/11
Last modified on 2021/08/11 16:38:13

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Basic information

Public title

Investigation of the interrelation among mental, physical and gut microbiota in the postpartum mother and infants

Acronym

Investigation of the interrelation among mental, physical and gut microbiota in the postpartum mother and infants

Scientific Title

Investigation of the interrelation among mental, physical and gut microbiota in the postpartum mother and infants

Scientific Title:Acronym

Investigation of the interrelation among mental, physical and gut microbiota in the postpartum mother and infants

Region

Japan


Condition

Condition

Not applicable

Classification by specialty

Not applicable

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

1. We investigate the interrelation between mind, body and gut in postpartum women.

Basic objectives2

Others

Basic objectives -Others

2. We investigate the interrelation between mind, body and gut in infant.
3. We assess the impact of mothers' mind and body on development of infant mind.

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

We evaluate mind and body at 3-5 and 9-11 months postpartum.

Key secondary outcomes

We assess mother-infant interaction on development of infant mind.


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

Mother over 20 years olds and her infant within a year after childbirth


Key exclusion criteria

1.Subjects who have under treatment or a history of serious disease (e.g., cancer, stroke, or heart disease)
2.Subjects who are judged inappropriate to enroll in this study by the investigator

Target sample size

140


Research contact person

Name of lead principal investigator

1st name Keisuke
Middle name
Last name Hagihara

Organization

Graduate School of Medicine, Osaka University

Division name

Department of Advanced Hybrid Medicine

Zip code

565-0871

Address

2-2, Yamadaoka, Suita, Osaka

TEL

06-6210-8349

Email

k.hagihara@imed3.med.osaka-u.ac.jp


Public contact

Name of contact person

1st name Keisuke
Middle name
Last name Hagihara

Organization

Graduate School of Medicine, Osaka University

Division name

Department of Advanced Hybrid Medicine

Zip code

565-0871

Address

2-2, Yamadaoka, Suita, Osaka

TEL

06-6210-8349

Homepage URL


Email

k.hagihara@imed3.med.osaka-u.ac.jp


Sponsor or person

Institute

Osaka University

Institute

Department

Personal name



Funding Source

Organization

Self funding

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor

Developmental Science Laboratory
Graduate School of Education, Kyoto University

Name of secondary funder(s)



IRB Contact (For public release)

Organization

Osaka University Clinical Research Review Committee

Address

2-2, Yamadaoka, Suita, Osaka

Tel

06-6210-8289

Email

rinri@hp-crc.med.osaka-u.ac.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

2021 Year 08 Month 11 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

Preinitiation

Date of protocol fixation

2019 Year 08 Month 15 Day

Date of IRB


Anticipated trial start date

2020 Year 09 Month 01 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

Prospective cohort studies
We assess the following contents at 3 to 5 months and 9 to 11 months after childbirth.
[Mother]
1. Physical assessment such as hand grip strength, and body composition analysis
2. Psychological assessment such as the Center for Epidemiologic Studies Depression Scale (CES-D), Resilience scale
3. Autonomic nervous activity by recording heart rate
4. Gut microbiota
5. Hormone concentration
6. Questionnaires about lifestyle, eating and sleeping habit
[Infant]
1. Assessment of infant development
2. Autonomic nervous activity by recording heart rate
3. Gut microbiota
4. Hormone concentration
5. Questionnaires about lifestyle, eating and sleeping habit


Management information

Registered date

2021 Year 08 Month 11 Day

Last modified on

2021 Year 08 Month 11 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046509


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name