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
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
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
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
