UMIN-ICDS 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

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 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

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

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_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