UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022698 |
|---|---|
| Receipt number | R000007082 |
| Scientific Title | Effect of Clostridium butyricum on Clostridium difficile in the fecus due to antibiotics:randomized prospective study |
| Date of disclosure of the study information | 2016/06/11 |
| Last modified on | 2016/06/11 02:26:21 |
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Basic information
Public title
Effect of Clostridium butyricum on Clostridium difficile in the fecus due to antibiotics:randomized prospective study
Acronym
Effect of Clostridium butyricum on CD in the fecus due to antibiotics
Scientific Title
Effect of Clostridium butyricum on Clostridium difficile in the fecus due to antibiotics:randomized prospective study
Scientific Title:Acronym
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
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
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
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Imaeda |
Organization
Saitama Medical University
Division name
Department of General Internal Medicine
Zip code
Address
38 Morohongo, Moroyama-machi, Iruma-gun, Saitama
TEL
049-276-1667
imaedahi@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Imaeda |
Organization
Saitama Medical University
Division name
Department of General Internal Medicine
Zip code
Address
38 Morohongo, Moroyama-machi, Iruma-gun, Saitama
TEL
049-276-1667
Homepage URL
imaedahi@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical University
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
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
Completed
Date of protocol fixation
| 2011 | Year | 10 | Month | 01 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007082
