UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058551 |
|---|---|
| Receipt number | R000066955 |
| Scientific Title | Effects of consumption of the test food on the vaginal environment in healthy Adult women.: a randomized, placebo-controlled, double-blind, parallel-group comparison study |
| Date of disclosure of the study information | 2025/07/22 |
| Last modified on | 2025/07/22 19:00:28 |
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Basic information
Public title
Effects of consumption of the test food on the vaginal environment in healthy adult women.
Acronym
Effects of consumption of the test food on the vaginal environment in healthy Adult women.
Scientific Title
Effects of consumption of the test food on the vaginal environment in healthy Adult women.: a randomized, placebo-controlled, double-blind, parallel-group comparison study
Scientific Title:Acronym
Effects of consumption of the test food on the vaginal environment in healthy Adult women.
Region
| Japan |
Condition
Condition
Healthy Japanese
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the effects of consumption of the test food on the vaginal environment in healthy adult women.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1. The measured value of Nugent Score at 12 weeks after intervention (12w)
Key secondary outcomes
1. The change and percentage change of Nugent Score at 12w from screening (Scr)
2. The measured values of Lactobacillus type, Gardnella type, and Mobiluncus type at 12w, as well as their changes and percentage changes from Scr
3. The measured values of vaginal odor, vaginal dryness, vaginal itching, vaginal discomfort, vulvar pigmentation, vulvar dryness, vulvar itching, vulvar discomfort, amount of vaginal discharge, volume of menstrual bleeding, menstrual pain, menstrual distress, and pain during sexual intercourse (visual analogue scale; VAS) at 12w, as well as their changes and percentage changes from Scr
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Food |
Interventions/Control_1
Duration: 12 weeks
Test product: Flavonoid.
Interventions/Control_2
Duration: 12 weeks
Test product: Placebo
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. Japanese
2. Women
3. Adults
4. Healthy individuals
5. Individuals whose Nugent Score is less than 7
Key exclusion criteria
1. Individuals who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, or myocardial infarction
2. Individuals who have a pacemaker or an implantable cardioverter defibrillator
3. Individuals who are undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, chronic kidney disease, cerebrovascular disorder, rheumatic disease, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases
4. Individuals who are diagnosed with bacterial vaginosis, cervical cancer, or sexually transmitted disease
5. Individuals who are taking "Foods for Specified Health Uses" or "Foods with Functional Claims"
6. Individuals who are taking or using medicines (including herbal medicines) or supplements
7. Individuals who are taking or using medicines related to gynecology such as the pill
8. Individuals who cannot collect vaginal secretions according to the established procedure with a dedicated kit
9. Individuals who are allergic to medicines or foods related to the test product, particularly those allergic to citrus fruit
10. Individuals with irregular sleeping duration or patterns due to night shifts or similar work, or with irregular lifestyles
11. Individuals who currently smoke or began smoking cessation within three months before providing informed consent
12. Individuals who habitually drink >= 60 g/day of alcohol
13. Individuals who are pregnant, lactating, or planning to become pregnant during this study
14. Individuals who have been enrolled in other clinical studies within the last 28 days before the agreement to participate in this study or plan to participate in another study during this study
15. Individuals who are judged as ineligible to participate in this study by the physician
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Tsuyoshi |
| Middle name | |
| Last name | Takara |
Organization
Medical Corporation Seishinkai, Takara Clinic
Division name
Director
Zip code
141-0022
Address
9F Taisei Bldg., 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan
TEL
03-5793-3623
t-takara@takara-clinic.com
Public contact
Name of contact person
| 1st name | Naoko |
| Middle name | |
| Last name | Suzuki |
Organization
ORTHOMEDICO Inc.
Division name
R&D Department
Zip code
112-0002
Address
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan
TEL
03-3818-0610
Homepage URL
nao@orthomedico.jp
Sponsor or person
Institute
Toyo Sugar Refining Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Toyo Sugar Refining 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
The ethical committee of the Takara Clinic, Medical Corporation Seishinkai
Address
9F Taisei Bldg., 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan
Tel
03-5793-3623
IRB@takara-clinic.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
医療法人社団盛心会 タカラクリニック (東京都)
Medical Corporation Seishinkai, Takara Clinic (Tokyo, Japan)
南町医院 (東京都)
Nerima Medical Association, Minami-machi Clinic (Tokyo, Japan)
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 07 | Month | 22 | 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
| 2025 | Year | 06 | Month | 24 | Day |
Date of IRB
| 2025 | Year | 06 | Month | 24 | Day |
Anticipated trial start date
| 2025 | Year | 07 | Month | 22 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 22 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
<Statistical analysis details>
Subgroups will be constructed based on the factors of the following variables.
Number of births: 2 or more / Less than 2
Frequency of sexual intercourse: At least once a year and at least twice a month at Scr / At least once a year and less than twice a month at Scr
Nugent Score: Nugent Score of 4 or higher at Scr / Lactobacillus type of 1 or higher at Scr / Gardnerella type of 1 or higher at Scr / Mobiluncus type of 1 or higher at Scr
Management information
Registered date
| 2025 | Year | 07 | Month | 22 | Day |
Last modified on
| 2025 | Year | 07 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066955
