UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020766 |
|---|---|
| Receipt number | R000023943 |
| Scientific Title | Fecal microbiota transplantation for Clostridium difficile infection |
| Date of disclosure of the study information | 2016/01/27 |
| Last modified on | 2021/01/30 09:55:14 |
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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
Refractory Clostridium difficile infection
Classification by specialty
| Medicine in general | Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to provide a fecal microbiota transplantation (FMT) as a treatment option for refractory Clostridium difficile infection (CDI).
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Recurrence rate of CDI at 2 months after FMT
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
| 20 | years-old | <= |
Age-upper limit
| 120 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Refractory CDI
(2) Refractory to at least single antibiotic treatment
(3) Eligible as a result of screening tests
Key exclusion criteria
(1) Unable to find appropriate donor
(2) Immunosuppressive state including chemotherapy, HIV infection and prednisolone administration
(3) Pregnancy
(4) Antibiotic treatment other than refractory Clostridium difficile infection
(5) Age under 20 years old
(6) Unable to undergo colonoscopy
(7) The attending physician determines that the subject is unsuitable for this study
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | Akira |
| Middle name | |
| Last name | Andoh |
Organization
Shiga University of Medical Science
Division name
Division of Gastroenterology
Zip code
520-2192
Address
Seta-Tsukinowa, Otsu
TEL
077-548-2217
hqmed2@belle.shiga-med.ac.jp
Public contact
Name of contact person
| 1st name | Shigeki |
| Middle name | |
| Last name | Bamba |
Organization
Shiga University of Medical Science
Division name
Division of Gastroenterology
Zip code
520-2192
Address
Seta-Tsukinowa, Otsu
TEL
077-548-2217
Homepage URL
sb@belle.shiga-med.ac.jp
Sponsor or person
Institute
Shiga University of Medical Science
Institute
Department
Personal name
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
Shiga University of Medical Science
Address
Seta-Tsukinowa, Otsu, Shiga
Tel
077-548-2217
sb@belle.shiga-md.ac.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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 01 | Month | 27 | Day |
Related information
URL releasing protocol
https://www.shiga-med.ac.jp/hospital/doc/department/department/digestive_int/index.html
Publication of results
Unpublished
Result
URL related to results and publications
https://www.shiga-med.ac.jp/hospital/doc/department/department/digestive_int/index.html
Number of participants that the trial has enrolled
8
Results
8 patients were successfully treated with FMT
Results date posted
| 2021 | Year | 01 | Month | 30 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Recurrent CDI patients
Participant flow
After screening, FMT was performed
Adverse events
None
Outcome measures
Response rate
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 09 | Month | 21 | Day |
Date of IRB
| 2016 | Year | 01 | Month | 27 | Day |
Anticipated trial start date
| 2016 | Year | 01 | Month | 27 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 01 | Month | 27 | Day |
Last modified on
| 2021 | Year | 01 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023943
