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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000016900
Receipt No. R000019617
Scientific Title Fecal microbiota transplantation for Clostridium difficile infection
Date of disclosure of the study information 2015/03/24
Last modified on 2018/09/25

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Basic information
Public title Fecal microbiota transplantation for Clostridium difficile infection
Acronym Fecal microbiota transplantation for Clostridium difficile infection
Scientific Title Fecal microbiota transplantation for Clostridium difficile infection
Scientific Title:Acronym Fecal microbiota transplantation for Clostridium difficile infection
Region
Japan

Condition
Condition Pseudomembranous colitis, Clostridium difficile infection
Classification by specialty
Medicine in general Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Assessment of safety and efficacy of fecal microbiota transplantation for patients with Clostridium difficile infection
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Recurrent rate
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 Fecal microbiota transplantation
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients with Clostridium difficile infection
Key exclusion criteria Declined patients
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akira Andoh
Organization Shiga University of Medical Science
Division name Division of Gastroenterology
Zip code
Address Seta-Tsukinowa, Otsu
TEL 0775482217
Email andoh@belle.shiga-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shigeki Bamba
Organization Shiga University of Medical Science
Division name Division of Gastroenterology
Zip code
Address Seta-Tsukinowa, Otsu
TEL 0775482217
Homepage URL
Email sb@belle.shiga-med.ac.jp

Sponsor
Institute Shiga University of Medical Science
Institute
Department

Funding Source
Organization Shiga University of Medical Science
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
Address
Tel
Email

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
2015 Year 03 Month 24 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 Open public recruiting
Date of protocol fixation
2015 Year 03 Month 24 Day
Date of IRB
Anticipated trial start date
2015 Year 03 Month 24 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
2015 Year 03 Month 24 Day
Last modified on
2018 Year 09 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019617

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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