UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018731 |
|---|---|
| Receipt number | R000021667 |
| Scientific Title | A study of usefulness of fecal microbiota transplantation for refractory Clostridium difficile infection |
| Date of disclosure of the study information | 2015/09/01 |
| Last modified on | 2023/03/30 18:03:58 |
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Basic information
Public title
A study of usefulness of fecal microbiota transplantation for refractory Clostridium difficile infection
Acronym
A study of usefulness of fecal microbiota transplantation for refractory Clostridium difficile infection
Scientific Title
A study of usefulness of fecal microbiota transplantation for refractory Clostridium difficile infection
Scientific Title:Acronym
A study of usefulness of fecal microbiota transplantation for refractory Clostridium difficile infection
Region
| Japan |
Condition
Condition
Reccurent Clostridium difficile infection
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify that efficacy and safety of fecal microbiota trasplantation for recurrent C. difficile infection.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Relapse rate of C. difficile infection within 10 weeks after FMT.
Key secondary outcomes
change of diarrhea,disappearance of CD toxin,change of intestinal flora,relationship between donar and recipient intestinal flora,adverse event,relapse rate within 6 months.
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
infusion of solusion of donor feces to recipient's intestine.
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
| 15 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Recurrent C. difficile infection even with enough treatment, i.e. vancomycin or metronidazole for more than 10 days.
Key exclusion criteria
1) Receiving other antibiotics for C. difficile infection.
2) Receiving prednisolone 60 mg/day or more.
3) Complication of Severe infection.
4) Complication of mental desease.
5) Pregnant and nursing women
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Mitsuhiro |
| Middle name | |
| Last name | Fujishiro |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Gastroenterology and hepatology
Zip code
466-8550
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Aichi 466-8550, Japan
TEL
+81-52-744-2164
hgoto@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Tsunaki |
| Middle name | |
| Last name | Sawada |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
466-8550
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Aichi 466-8550, Japan
TEL
+81-52-741-2172
Homepage URL
t.sawada@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University Graduate School of Medicine, Department of Gastroentrology and hepatology
Institute
Department
Personal name
Funding Source
Organization
Nagoya University Graduate School of Medicine
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
Nagoya University Certified Review Board
Address
65-banchi, Tsurumai-cho, Showa-ku, Aichi
Tel
0527442881
ethics@med.nagoya-u.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
名古屋大学医学部附属病院（愛知県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 09 | Month | 01 | 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
Terminated
Date of protocol fixation
| 2015 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2015 | Year | 09 | Month | 01 | Day |
Anticipated trial start date
| 2015 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 09 | Month | 01 | 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 | 08 | Month | 20 | Day |
Last modified on
| 2023 | Year | 03 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021667
