UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056312 |
|---|---|
| Receipt number | R000064343 |
| Scientific Title | Effects of a dairy ingredient on vaginal environment in postmenopausal women: a randomized, double-blind, placebo-controlled trial |
| Date of disclosure of the study information | 2024/11/29 |
| Last modified on | 2025/12/01 09:14:54 |
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Basic information
Public title
Effects of a dairy ingredient on vaginal environment in postmenopausal women: a randomized, double-blind, placebo-controlled trial
Acronym
Effects of a dairy ingredient on vaginal environment in postmenopausal women
Scientific Title
Effects of a dairy ingredient on vaginal environment in postmenopausal women: a randomized, double-blind, placebo-controlled trial
Scientific Title:Acronym
Effects of a dairy ingredient on vaginal environment in postmenopausal women
Region
| Japan |
Condition
Condition
None (Healthy subjects)
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of a dairy ingredient on the vaginal environment
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Nugent score
Key secondary outcomes
Nugent subscore
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
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Ingestion of dairy ingredient for 12 weeks
Interventions/Control_2
Ingestion of placebo for 12 weeks
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
| 50 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Female
Key inclusion criteria
1)Female subjects
2)Subjects between 50 to 65 years old
3)More than 1 year has passed since the last menstrual period
Key exclusion criteria
1)Subjects diagnosed with bacterial vaginosis within the past 3 months
2)Subjects with Nugent score of 7 or higher
3)Subjects who have received oral or intravenous antibiotic treatment within the past 3 months from the time of screening
4)Subjects who plan to make major lifestyle changes (diet, sleep, exercise, etc.) during the study period
5)Subjects having a milk allergy
6)Subjects who regularly consume foods containing a dairy ingredient to be evaluated
7)Subjects who have serious disease in the liver, kidney heart, lung, gastrointestinal tract, blood, endocrine system, or metabolic system etc. Or those who have serious medical history of these
8)Subjects who have medical history of drug allergy or severe food allergy
9)Others who have been determined as ineligible for the research subject of this study, judging by the principal investigator on the findings of their background, physical observations, physical examination, and so on
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Yayoi |
| Middle name | |
| Last name | Sugimori |
Organization
Bunkyo Garden Women's Clinic
Division name
Director
Zip code
112-0002
Address
1-1-7 Koishikawa, Bunkyo-ku, Tokyo
TEL
03-3818-1132
clinic-trial@bg-josei-clinic.jp
Public contact
Name of contact person
| 1st name | Tamaki |
| Middle name | |
| Last name | Furuhata |
Organization
EP Mediate Co., Ltd.
Division name
Development Department Trial Planning Section
Zip code
162-0821
Address
Kagurazaka AK Bldg., 1-8 Tsukudocho, Shinjuku-ku, Tokyo
TEL
070-3023-8207
Homepage URL
furuhata.tamaki686@eps.co.jp
Sponsor or person
Institute
Bunkyo Garden Women's Clinic
Institute
Department
Personal name
Funding Source
Organization
Morinaga Milk Industry 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
Medical Station Clinic Research Ethics Committee
Address
3-12-8, Takaban, Meguro-ku, Tokyo
Tel
03-6452-2712
nakagawa.akiko297@eps.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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 11 | Month | 29 | 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
| 2024 | Year | 11 | Month | 28 | Day |
Date of IRB
| 2024 | Year | 11 | Month | 28 | Day |
Anticipated trial start date
| 2025 | Year | 01 | Month | 08 | Day |
Last follow-up date
| 2025 | Year | 07 | Month | 08 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 11 | Month | 29 | Day |
Last modified on
| 2025 | Year | 12 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064343
