UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025745 |
|---|---|
| Receipt number | R000029588 |
| Scientific Title | The changes in vaginal flora by intake of lactobacillus. |
| Date of disclosure of the study information | 2017/01/20 |
| Last modified on | 2021/07/26 11:29:50 |
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Basic information
Public title
The changes in vaginal flora by intake of lactobacillus.
Acronym
The changes in vaginal flora by intake of lactobacillus.
Scientific Title
The changes in vaginal flora by intake of lactobacillus.
Scientific Title:Acronym
The changes in vaginal flora by intake of lactobacillus.
Region
| Japan |
Condition
Condition
menopause
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Taking the test beverage for 4 weeks and we evaluate the occupation rate of Lactobacillus in the vagina before and after intaking.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Taking the test beverage for 4 weeks and we evaluate the occupation rate of Lactobacillus in the vagina before and after intaking.
Key secondary outcomes
Taking the test beverage for 4 weeks and we evaluate the occupation rate of Lactobacillus Bifidobacterium around the anus before and after intaking.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
The subjects take lactobacillus beverage for 4 weeks.The placebo group take control beverages for 4 weeks.
Interventions/Control_2
The subjects take 200 ml per day both lactic acid bacteria beverage and control beverage. Lactobacillus beverage contains 100 mg of Lactobacillus gasseri OLL 2809.
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
| 40 | years-old | < |
Age-upper limit
| 70 | years-old | > |
Gender
Female
Key inclusion criteria
Postmenopausal women
Key exclusion criteria
Persons who have serious complications.
Those who judge that the research doctor is inappropriate.
Persons who are allergic to milk.
Those who participated in other trials or clinical trials within one month.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Kazuhiro |
| Middle name | |
| Last name | Sugihara |
Organization
Hamamatsu University School of Medicine
Division name
Obstetrics and Gynecology
Zip code
431-3192
Address
Handayama 1-20-1 Higasi-ku Hamamatsu city Shizuoka prefecture
TEL
053-435-2309
sugihara@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | Masashi |
| Middle name | |
| Last name | Adachi |
Organization
Hamamatsu University School of Medicine
Division name
Obstetrics and Gynecology
Zip code
431-3192
Address
Handayama 1-20-1 Higasi-ku Hamamatsu city Shizuoka prefecture
TEL
053-435-2309
Homepage URL
adachi@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Meiji
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
Clinical Research Ethics Committee
Address
1-20-1, Handayama, Higashi, Hamamatsu City, Shizuoka Prefecture
Tel
053-435-1111
rinri@hama-med.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
2016-022
Org. issuing International ID_1
Meiji Ethics Review Committee
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
浜松医科大学附属病院
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 01 | Month | 20 | 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
Terminated
Date of protocol fixation
| 2017 | Year | 01 | Month | 05 | Day |
Date of IRB
| 2016 | Year | 12 | Month | 15 | Day |
Anticipated trial start date
| 2017 | Year | 01 | Month | 05 | Day |
Last follow-up date
| 2019 | Year | 01 | Month | 04 | Day |
Date of closure to data entry
| 2019 | Year | 01 | Month | 04 | Day |
Date trial data considered complete
| 2019 | Year | 01 | Month | 04 | Day |
Date analysis concluded
| 2019 | Year | 01 | Month | 04 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 01 | Month | 19 | Day |
Last modified on
| 2021 | Year | 07 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029588
| Research Plan | |
|---|---|
| Registered date | File name |
| 2021/07/26 | (4)研究計計画.改.doc |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
