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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000015476
Receipt No. R000017772
Scientific Title A clinical study evaluating the effectiveness of Lactobacillus vaginal suppositories in patients with recurrent urinary tract infection
Date of disclosure of the study information 2014/10/20
Last modified on 2014/10/20

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Basic information
Public title A clinical study evaluating the effectiveness of Lactobacillus
vaginal suppositories in patients with recurrent urinary tract infection
Acronym effectiveness of Lactobacillus
vaginal suppositories in patients with recurrent urinary tract infection
Scientific Title A clinical study evaluating the effectiveness of Lactobacillus
vaginal suppositories in patients with recurrent urinary tract infection
Scientific Title:Acronym effectiveness of Lactobacillus
vaginal suppositories in patients with recurrent urinary tract infection
Region
Japan

Condition
Condition recurrent urinary tract infection
Classification by specialty
Urology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the effectiveness of Lactobacillus vaginal suppositories in patients with recurrent urinary tract infection
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The reccurence rate of urinary tract infection
Key secondary outcomes

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 Administration of Lactobacillus vaginal suppositories
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
20 years-old <=
Age-upper limit
79 years-old >=
Gender Female
Key inclusion criteria recurrent acute uncomplicated urinary tract infection
Key exclusion criteria complicated urinary tract infection
Target sample size 20

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 086-235-7844
Email ishii-a@cc.okayama-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Koichiro Wada
Organization Okayama University Medical School of Medicine, Dentistry and Pharmaceutical Sciences
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 Medical School of Medicine, Dentistry and Pharmaceutical Sciences
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, Science and Technology, MEXT
Organization
Division
Category of Funding Organization
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
2014 Year 10 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 Open public recruiting
Date of protocol fixation
2013 Year 11 Month 19 Day
Date of IRB
Anticipated trial start date
2014 Year 02 Month 03 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 10 Month 20 Day
Last modified on
2014 Year 10 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017772

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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