UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000048591
Receipt number R000055367
Scientific Title QOL survey of pregnant women during health guidance focusing the intestinal environment
Date of disclosure of the study information 2022/08/04
Last modified on 2023/08/09 15:09:34

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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

Obstetrics 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

Fukuoka Prefectural Midwifery Association

Division name

Fukuoka Prefectural Midwifery Association

Zip code

814-0014

Address

1-3-41 Hirao, Chuou-ku, Fukuoka City, Fukuoka, JAPAN

TEL

092-521-2025

Email

kayoswitch@gmail.com


Public contact

Name of contact person

1st name Kayo
Middle name
Last name Sato

Organization

Fukuoka Prefectural Midwifery Association

Division name

Fukuoka Prefectural Midwifery Association

Zip code

814-0014

Address

1-3-41 Hirao, Chuou-ku, Fukuoka City, Fukuoka, JAPAN

TEL

092-521-2025

Homepage URL


Email

kayoswitch@gmail.com


Sponsor or person

Institute

Fukuoka Prefectural Midwifery Association

Institute

Department

Personal name



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

University of Health and Welfare
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

2023 Year 08 Month 09 Day



Link to view the page

Value
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