UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Investigation of efficacy of Lactobacillus tablets to rectal and vaginal flora in Japanese postmenopausal women
Title of the study (Brief title)	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	Ayano Ishii
Organization	Okayama University Hospital
Division name	Integrated Support Center for Patients and Self-learning
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	Kouichirou Wada
Organization	Okayama University Graduate School of Medicine,Dentistry and Phaemaceutical SciencesHospital
Division name	Department of Urology
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)

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

Progress
Recruitment status	Recruiting
Date of protocol fixation	2016 Year 08 Month 30 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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