UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015476 |
|---|---|
| Receipt number | 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 12:17:17 |
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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
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
gmd17055@s.okadai.jp
Sponsor or person
Institute
Okayama University Medical School of Medicine, Dentistry and Pharmaceutical Sciences
Institute
Department
Personal name
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
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
Value
https://center6.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 | |
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| Registered date | File name |
