UMIN-CTR Clinical Trial

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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000038962