UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025601 |
|---|---|
| Receipt number | R000027288 |
| Scientific Title | Investigation of efficacy of Lactobacillus tablets to rectal and vaginal flora in Japanese postmenopausal women |
| Date of disclosure of the study information | 2017/01/10 |
| Last modified on | 2017/01/10 18:57:44 |
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Basic information
Public title
Investigation of efficacy of Lactobacillus tablets to rectal and vaginal flora in Japanese postmenopausal women
Acronym
Effect of Lactobacillus tablets to rectal and vaginal flora
Scientific Title
Investigation of efficacy of Lactobacillus tablets to rectal and vaginal flora in Japanese postmenopausal women
Scientific Title:Acronym
Effect of Lactobacillus tablets to rectal and vaginal flora
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of study is to investigate influence of Lactobacillus tablets to rectal and vaginal flora.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Change of rectal and vaginal flora after administration of Lactobacillus tablets
Key secondary outcomes
If participants suffer from urinary tract infection during administration of Lactobacillus tablets, bacterial isolates will be examined whether the isolates is from rectum or vagina.
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
| Medicine |
Interventions/Control_1
Lactobacillus (Rabure:Kagome) is taken 1 capsule a day for 30 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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
1)Postmenopausal women
2)The presence or absence of the urinary tract basis disease is irrelevant.
3)Outpatient
Key exclusion criteria
1)Patients who already have urinary tract infection
2)Patients requiring urological treatment due to urolithiasis, hydronephrosis, urinary tract tumors, etc.
3)Urethral catheter indwelling patient
4)Patients with poor control, severe underlying diseases and complications
5)Allergic patients of lactic acid bacteriaproducts
6)Patient deemed inappropriate
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ayano Ishii |
Organization
Okayama University Hospital
Division name
Integrated Support Center for Patients and Self-learning
Zip code
Address
2-5-1,Shikata-cho,Kita-ku,Okayama
TEL
086-235-7287
ishii-a@cc.okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kouichirou Wada |
Organization
Okayama University Graduate School of Medicine,Dentistry and Phaemaceutical SciencesHospital
Division name
Department of Urology
Zip code
Address
2-5-1,Shikata-cho,Kita-ku,Okayama
TEL
086-235-7287
Homepage URL
gmd17055@s.okadai.jp
Sponsor or person
Institute
Okayama University
Institute
Department
Personal name
Funding Source
Organization
Ministry of education
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2017 | Year | 01 | Month | 10 | 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
Date of protocol fixation
| 2016 | Year | 08 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 10 | Month | 19 | Day |
Last follow-up date
| 2020 | 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
| 2017 | Year | 01 | Month | 10 | Day |
Last modified on
| 2017 | Year | 01 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027288
