UMIN-CTR Clinical Trial

Basic information
Public title	QOL survey of pregnant women during health guidance focusing the intestinal environment
Acronym	QOL survey of pregnant women during health guidance focusing the intestinal environment
Scientific Title	QOL survey of pregnant women during health guidance focusing the intestinal environment
Scientific Title:Acronym	QOL survey of pregnant women during health guidance focusing the intestinal environment
Region	Japan

Condition
Condition	Pregnancy
Classification by specialty	Obsterics and gynecology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	As part of activities that are conscious of the intestinal environment, follow up on changes in quality of life when lactic acid bacteria-fermented soymilk extract is ingested for 16 weeks.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	QOL (Abdominal symptoms, skin and sleep conditions, mood and emotions, and other physical conditions)
Key secondary outcomes	Refer to the midwifery record (various test results / progress of pregnancy, childbirth, postpartum, and child status)

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Intake 10ml of lactic acid bacteria fermented soymilk extract daily for 16 weeks.
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	18 years-old <=
Age-upper limit	Not applicable
Gender	Female
Key inclusion criteria	1. Persons who received a sufficient explanation of the purpose and contents of the exam, have the capacity to consent, applied with free will with sufficient understanding, and agreed to participate with a written document 2. Healthy Japanese pregnant woman who are 18 years old or more
Key exclusion criteria	1. Minors 2. Persons who have chronic illness 3. Persons who are taking medications that affect the intestinal environment, such as intestinal medicines, laxatives, and antibiotics 4. Persons who are allergic to soy 5. Persons who have participated in other tests within the first month before the start of the test, or those who intend to participate in another exam after consenting to this exam 6. Persons who cannot use smartphones or PC
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Kayo Middle name Last name Sato
Organization	International University of Health and Welfare
Division name	Department of Midwifery, Graduate School of Health and Welfare Sciences
Zip code	814-0001
Address	2-4-16 Momochihama Sawara-ku, Fukuoka City, Fukuoka, JAPAN
TEL	092-407-1916
Email	kayos@iuhw.ac.jp

Public contact
Name of contact person	1st name Kayo Middle name Last name Sato
Organization	International University of Health and Welfare
Division name	Department of Midwifery, Graduate School of Health and Welfare Sciences
Zip code	814-0001
Address	2-4-16 Momochihama Sawara-ku, Fukuoka City, Fukuoka, JAPAN
TEL	092-407-1916
Homepage URL
Email	kayos@iuhw.ac.jp

Sponsor
Institute	International University of Health and Welfare
Institute
Department

Funding Source
Organization	B&S corporation Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	Maternity hospital Mamita Fukuoka Prefectural University B&S corporation Co., Ltd.
Name of secondary funder(s)

IRB Contact (For public release)
Organization	The Research Ethics Committee of Fukuoka Prefectural Midwifery Association
Address	1-3-41 Hirao, Chuo-ku Fukuoka city, Fukuoka, JAPAN
Tel	092-521-2025
Email	mwfukurinri@gmail.com

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 08 Month 04 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	2022 Year 07 Month 27 Day
Date of IRB	2022 Year 07 Month 27 Day
Anticipated trial start date	2022 Year 08 Month 08 Day
Last follow-up date	2027 Year 08 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2022 Year 08 Month 04 Day
Last modified on	2022 Year 08 Month 08 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055367

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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