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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000034173
Receipt No. 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 2019/09/18

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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
Email 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
Email Kshigehara0415@yahoo.co.jp

Sponsor
Institute Department of Integrative Cancer Therapy and Urology, Kanazawa University Graduate School of Medical Science
Institute
Department

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
Email 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
2020 Year 03 Month 31 Day
Date of closure to data entry
2020 Year 09 Month 30 Day
Date trial data considered complete
2020 Year 12 Month 31 Day
Date analysis concluded
2021 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.

Management information
Registered date
2018 Year 09 Month 17 Day
Last modified on
2019 Year 09 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038962

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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