UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of Clostridium butyricum on Clostridium difficile in the fecus due to antibiotics:randomized prospective study
Title of the study (Brief title)	Effect of Clostridium butyricum on CD in the fecus due to antibiotics
Region	Japan

Condition
Condition	bacterial infection administered antibioticsd
Classification by specialty	Medicine in general Gastroenterology Infectious disease
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to evaluate efficacy of Clostridium butyricum for prevention of Clostridium difficile in the fecus due to antibiotics
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	CD or CD toxin A/B i nthe fecus after 2 weeks
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Medicine
Interventions/Control_1	group with administration of Clostridium butylicum
Interventions/Control_2	group without administration of Clostridium butylicum
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	bacterial infection administered antibiotics
Key exclusion criteria	bacterial enterocolitis
Target sample size	120

Research contact person
Name of lead principal investigator	Hiroyuki Imaeda
Organization	Saitama Medical University
Division name	Department of General Internal Medicine
Address	38 Morohongo, Moroyama-machi, Iruma-gun, Saitama
TEL	049-276-1667
Email	imaedahi@saitama-med.ac.jp

Public contact
Name of contact person	Hiroyuki Imaeda
Organization	Saitama Medical University
Division name	Department of General Internal Medicine
Address	38 Morohongo, Moroyama-machi, Iruma-gun, Saitama
TEL	049-276-1667
Homepage URL
Email	imaedahi@saitama-med.ac.jp

Sponsor
Institute	Saitama Medical University
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2016 Year 06 Month 11 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 10 Month 01 Day
Anticipated trial start date	2011 Year 10 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 06 Month 11 Day
Last modified on	2016 Year 06 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007082