UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034173 |
|---|---|
| Receipt number | R000038962 |
| Scientific Title | The efficacy of Clostridium butyricum products (Miya-BM) on urinary tract infections among the patients with long-term urethral catheterization |
| Date of disclosure of the study information | 2018/09/18 |
| Last modified on | 2021/03/24 16:07:13 |
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Basic information
Public title
The efficacy of Clostridium butyricum products (Miya-BM) on urinary tract infections among the patients with long-term urethral catheterization
Acronym
The efficacy of Clostridium butyricum products among patients with urethral catheterization
Scientific Title
The efficacy of Clostridium butyricum products (Miya-BM) on urinary tract infections among the patients with long-term urethral catheterization
Scientific Title:Acronym
The efficacy of Clostridium butyricum products among patients with urethral catheterization
Region
| Japan |
Condition
Condition
Patients with long-term urethral catheterization for more than 3 months
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate prospectively efficacy of Clostridium butyricum products for chronic urinary tract infections among patients with long-term urethral catheterization
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Any troubles and symptoms by urethral catheter
Key secondary outcomes
Symptomatic UTIs, necessity of antibiotic treatment, urinalysis, urine culture, stool culture
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)20 years and over
2)Patients with urethral catheterization for more than 3 months, and who are required to continue it in the future
3)Patients planning to administer Clostridium butyricum products for Defecation disorders
Key exclusion criteria
Patients who have any of the following conditions are excluded.
1)Patients who have difficulty in oral administration of Clostridium butyricum products (Administration of drugs from gastrostomy or gastric tube is acceptable for inclusion)
2)Patients who provided written informed consent regarding study participation from themselves or their family.
3)Patients who judged by the investigator as ineligibility for entry
4)Patients with administrations of any antibiotics within one month.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Kazuyoshi |
| Middle name | |
| Last name | Kazuyoshi |
Organization
Kanazawa University Graduate School of Medical Science
Division name
Department of Integrative Cancer Therapy and Urology
Zip code
920-8641
Address
13-1 Takaramachi Kanazawa Ishikawa Japan
TEL
076-265-2393
Kshigehara0415@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Kazuyoshi |
| Middle name | |
| Last name | Kazuyoshi |
Organization
Kanazawa University Graduate School of Medical Science
Division name
Department of Integrative Cancer Therapy and Urology
Zip code
920-8641
Address
13-1 Takaramachi Kanazawa Ishikawa Japan
TEL
076-265-2393
Homepage URL
Kshigehara0415@yahoo.co.jp
Sponsor or person
Institute
Department of Integrative Cancer Therapy and Urology, Kanazawa University Graduate School of Medical Science
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Innovative Clinical Research Center, Kanazawa University
Address
13-1, Takaramachi, Kanazawa, Ishikawa
Tel
076-265-2000
crc.irb-knz@esct.jp
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
金沢大学医薬保健研究域 医学系泌尿器集学的治療学（金沢大学附属病院 泌尿器科）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 09 | Month | 18 | 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
Enrolling by invitation
Date of protocol fixation
| 2018 | Year | 06 | Month | 30 | Day |
Date of IRB
| 2018 | Year | 08 | Month | 22 | Day |
Anticipated trial start date
| 2018 | Year | 09 | Month | 21 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2022 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2023 | Year | 03 | Month | 31 | Day |
Other
Other related information
To evaluate efficacy of Clostridium butyricum products on incidences of any troubles by urethral catherter and symptomatic urinary tract infection. Observation is 3 months. Currently, 21 cases were included in this study.
Management information
Registered date
| 2018 | Year | 09 | Month | 17 | Day |
Last modified on
| 2021 | Year | 03 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038962
