UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059873 |
|---|---|
| Receipt number | R000068472 |
| Scientific Title | An observational study investigating the characteristics of the vaginal microbiota in Japanese women. |
| Date of disclosure of the study information | 2025/11/25 |
| Last modified on | 2025/11/25 13:53:31 |
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Basic information
Public title
An observational study investigating the characteristics of the vaginal microbiota in Japanese women.
Acronym
An observational study investigating the characteristics of the vaginal microbiota in Japanese women.
Scientific Title
An observational study investigating the characteristics of the vaginal microbiota in Japanese women.
Scientific Title:Acronym
An observational study investigating the characteristics of the vaginal microbiota in Japanese women.
Region
| Japan |
Condition
Condition
N/A
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to investigate the association between the vaginal microbiota of healthy premenopausal adult women and host baseline characteristics.
Basic objectives2
Others
Basic objectives -Others
Relevance
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Association between the vaginal microbiota and background information.
Key secondary outcomes
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
1,Women aged 18 years or older at the time of consent
2,Premenopausal at the time of consent
3,Having received a sufficient explanation of the study, adequately understood it, and provided written informed consent of their own free will
Key exclusion criteria
1.Women who are currently pregnant or may be pregnant
2.Women within six months postpartum
3.Women who have received oral or intravenous antibiotic therapy within the past two months
4.Women with a history of total hysterectomy or bilateral oophorectomy
5.Women who have a vaginal or uterine disease and are currently under treatment
6.Women who are under treatment for, or have a history of, malignant tumors, heart failure, or myocardial infarction
7.Women currently under treatment for any of the following chronic conditions: arrhythmia, liver dysfunction, chronic kidney disease, cerebrovascular disease, rheumatic disease, diabetes, dyslipidemia, hypertension, or other chronic diseases
8.Women with a colostomy
9.Women currently participating in another clinical study
10.Women otherwise deemed unsuitable as study participants by the principal investigator
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Kei |
| Middle name | |
| Last name | Yamana |
Organization
Meiji Holdings Co., Ltd.
Division name
Wellness Science Labs
Zip code
1-29-1
Address
Nanakuni, Hachiouji, Tokyo, Japan
TEL
042-632-5838
kei.yamana@meiji.com
Public contact
Name of contact person
| 1st name | Shoko |
| Middle name | |
| Last name | Ishii |
Organization
Meiji Holdings Co., Ltd.
Division name
Wellness Science Labs
Zip code
1-29-1
Address
Nanakuni, Hachiouji, Tokyo, Japan
TEL
042-632-5842
Homepage URL
project_Femtech@meiji.com
Sponsor or person
Institute
Meiji Holdings Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Meiji Holdings Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Meiji Institutional Review Board
Address
1-29-1 Nanakuni, Hachiouji, Tokyo, Japan
Tel
042-632-5900
MEIJI.IRB@meiji.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
| 2025 | Year | 11 | Month | 25 | 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
| 2025 | Year | 11 | Month | 14 | Day |
Date of IRB
| 2025 | Year | 11 | Month | 14 | Day |
Anticipated trial start date
| 2025 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study aims to investigate the association between the vaginal microbiota of healthy premenopausal adult women and host baseline characteristics.
Management information
Registered date
| 2025 | Year | 11 | Month | 25 | Day |
Last modified on
| 2025 | Year | 11 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068472
