UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019181 |
|---|---|
| Receipt number | R000022175 |
| Scientific Title | Fecal microbiota transplantation for refractory Clostridium difficile infection |
| Date of disclosure of the study information | 2015/09/30 |
| Last modified on | 2020/10/03 11:54:03 |
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Basic information
Public title
Fecal microbiota transplantation for refractory Clostridium difficile infection
Acronym
Fecal microbiota transplantation for refractory Clostridium difficile infection
Scientific Title
Fecal microbiota transplantation for refractory Clostridium difficile infection
Scientific Title:Acronym
Fecal microbiota transplantation for refractory 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 aim of this study is to confirm the efficacy and safety of fecal microbiota transplantation for refractory Clostridium difficile infection
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Recurrence rate of Clostridium difficile infection in 2 months after fecal microbiota transplantation
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1)Refractory Clostridium difficile infection
(2)Refractory to single antibiotic treatment
(2)After screening tests, donor and recipient should be matched and meet criteria for fecal microbiota transplantation.
Key exclusion criteria
(1)Unable to find donors
(2)Immunocompromised
(3)Pregnancy
(4)Under antibiotics threrapy for targeting other than refractory Clostridium difficile infection
(5)Infant
(6)Unable to undergo colonoscopy
(7)Attending physician has determined unsuitabe
Target sample size
10
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
hqgastro@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
Akira Andoh
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
Tel
0775482544
sb@belle.shiga-med.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
| 2015 | Year | 09 | Month | 30 | 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
8
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
| 2015 | Year | 09 | Month | 21 | Day |
Date of IRB
| 2015 | Year | 09 | Month | 21 | Day |
Anticipated trial start date
| 2015 | Year | 11 | Month | 01 | 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
| 2015 | Year | 09 | Month | 30 | Day |
Last modified on
| 2020 | Year | 10 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022175
