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UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000025601
Receipt No. 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

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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
Email 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
Email gmd17055@s.okadai.jp

Sponsor
Institute Okayama University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027288

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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