UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049695 |
|---|---|
| Receipt number | R000056604 |
| Scientific Title | Effect of use of test product on vaginal microbiota - Open label test - |
| Date of disclosure of the study information | 2022/12/19 |
| Last modified on | 2024/06/18 15:36:49 |
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Basic information
Public title
Effect of use of test product on vaginal microbiota
Acronym
Effect of use of test product on vaginal microbiota
Scientific Title
Effect of use of test product on vaginal microbiota
- Open label test -
Scientific Title:Acronym
Effect of use of test product on vaginal microbiota
- Open label test -
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate the effect of test product use on vaginal microbiota
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
vaginal microbiota
Key secondary outcomes
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
| Device,equipment |
Interventions/Control_1
Use test product for 3 days
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
| 20 | years-old | <= |
Age-upper limit
| 46 | years-old | > |
Gender
Female
Key inclusion criteria
(1) Subjects of men and women aged 20 to 40
(2) Subjects whose menstrual cycle is around 28 days
(3)Subjects who received sufficient explanation about the purpose and content of the test, had the ability to consent, voluntarily volunteered to participate after understanding it well, and agreed to participate in the test in writing
Key exclusion criteria
(1) Subjects with a history of diabetes, liver disease, renal disease, gastrointestinal disease, heart disease, respiratory disease, peripheral vascular disease, or other serious disease
(2) Subjects with diseases currently being treated
(3) Subjects with a history of gynecological disease (endometriosis, uterine fibroids, ovarian cysts, cervical cancer, uterine cancer, etc.)
(4) Subjects with food and drug allergies
(5) Female subjects who wish to become pregnant while participating in this study, female subjects who are pregnant (including those who may be pregnant) or who are breastfeeding
(6) Subjects using products or drugs that affect hormone balance
(7) Subjects receiving antibiotics
(8) Subjects who participate in strenuous sports and who are on a diet
(9)Subjects with irregular lifestyle
(10) Subjects who cannot stop taking health foods (including foods for specified health use and foods with functional claims) and quasi-drugs during the test period
(11) Subjects who are continuously receiving medical treatment (including OTC and prescription drugs)
(12) Subjects who consume alcohol excessively
(13) Subjects who cannot abstain from alcohol from the day before the test to the day of the test
(14) Subjects participating in or planning to participate in other clinical trials at the start of this study
(15) Subjects who are otherwise judged by the principal investigator or subinvestigator to be unsuitable for the study
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Naoki |
| Middle name | |
| Last name | Miura |
Organization
Miura Clinic, Medical Corporation Kanonkai
Division name
Internal medicine
Zip code
530-0044
Address
Higashitenma building 9F, 1-7-17, Higashitenma, Kita-ku, Osaka
TEL
06-6135-5200
info@miura-cl.jp
Public contact
Name of contact person
| 1st name | Makoto |
| Middle name | |
| Last name | Terashima |
Organization
Oneness Support Co., Ltd.
Division name
Clinical Trial Division
Zip code
530-0044
Address
Higashitenma building 4F, 1-7-17, Higashitenma, Kita-ku, Osaka,
TEL
0648018917
Homepage URL
mterashima@oneness-sup.co.jp
Sponsor or person
Institute
Miura Clinic, Medical Corporation Kanonkai
Institute
Department
Personal name
Funding Source
Organization
GRAPHICO, Inc.
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
Miura Clinic, Medical Corporation Kanonkai IRB
Address
Higashitenma building 4F, 1-7-17, Higashitenma, Kita-ku, Osaka
Tel
0648018917
mterashima@oneness-sup.co.jp
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
医療法人花音会みうらクリニック（大阪府） Miura Clinic, Medical Corporation Kanonkai（Osaka）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 12 | Month | 19 | 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
Completed
Date of protocol fixation
| 2022 | Year | 10 | Month | 17 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 20 | Day |
Anticipated trial start date
| 2022 | Year | 12 | Month | 19 | Day |
Last follow-up date
| 2023 | Year | 03 | 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 | 12 | Month | 05 | Day |
Last modified on
| 2024 | Year | 06 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056604
