UMIN-CTR Clinical Trial

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
Institute	Osaka University
Institute
Department

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046509