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UMIN-CTR Clinical Trial |
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Name | UMIN ID |
Recruitment status | Open public recruiting |
Unique ID issued by UMIN | UMIN000048591 |
Receipt No. | 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 | 2022/08/08 |
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 |
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Condition | ||
Condition | Pregnancy | |
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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 |
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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 |
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Target sample size | 200 |
Research contact person | |||||||
Name of lead principal investigator |
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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 | ||||||
kayos@iuhw.ac.jp |
Public contact | |||||||
Name of contact person |
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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 | |||||||
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 |
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 |
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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 |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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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 |