UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015115 |
|---|---|
| Receipt number | R000017575 |
| Scientific Title | Safety and efficacy of fecal microbiota transplantation for steroid resistant acute graft-versus-host disease of gut in allogeneic hematopoietic stem cell transplantation |
| Date of disclosure of the study information | 2015/06/11 |
| Last modified on | 2016/04/28 11:49:33 |
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Basic information
Public title
Safety and efficacy of fecal microbiota transplantation for steroid resistant acute graft-versus-host disease of gut in allogeneic hematopoietic stem cell transplantation
Acronym
Safety and efficacy of FMT for acute GVHD of gut in alloHSCT
Scientific Title
Safety and efficacy of fecal microbiota transplantation for steroid resistant acute graft-versus-host disease of gut in allogeneic hematopoietic stem cell transplantation
Scientific Title:Acronym
Safety and efficacy of FMT for acute GVHD of gut in alloHSCT
Region
| Japan |
Condition
Condition
Steroid resistant acute graft-versus-host disease of gut in allogeneic hematopoietic stem cell transplantation
Classification by specialty
| Medicine in general | Hematology and clinical oncology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of safety of fecal microbiota transplantation as a treatment for steroid resistant acute graft-versus-host disease in allogeneic hematopoietic stem cell transplantation
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Safety of fecal microbiota transplantation (FMT)
Key secondary outcomes
Efficacy for acute GVHD of gut
Efficacy for acute GVHD of skin or liver
Incidence of clostridium difficile infection
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
FMT, start as soon as possible after meeting inclusion criteria, up to 2 cycles.
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
1) Acute GVHD of gut
2) GVHD which does not improve despite adequate dose (1mg/kg/day or more of PSL) of steroid, or steroid dose is difficult to reduce because of exacerbation of GVHD.
3)Written informed consent
Key exclusion criteria
1)Steroid sensitive GVHD
2)Progressive GVHD despite steroid therapy (1mg/kg/day or more of PSL)
4)Diarrhea due to other cause
5)Inadequate condition as considered by primary physician
Target sample size
4
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuhiko Kakihana |
Organization
Tokyo Metropolitan Cancer and Infectious diseases Center, Komagome Hospital
Division name
Hematology division
Zip code
Address
3-18-22 Honkomagome, Bunkyo-ku, Tokyo 113-8677, Japan
TEL
03-3823-2101
kakihana@cick.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuhiko Kakihana |
Organization
Tokyo Metropolitan Cancer and Infectious diseases Center, Komagome Hospital
Division name
Hematology division
Zip code
Address
3-18-22 Honkomagome, Bunkyo-ku, Tokyo 113-8677, Japan
TEL
03-3823-2101
Homepage URL
kakihana@cick.jp
Sponsor or person
Institute
Tokyo Metropolitan Cancer and Infectious diseases Center, Komagome Hospital
Institute
Department
Personal name
Funding Source
Organization
Tokyo Metropolitan Cancer and Infectious diseases Center, Komagome Hospital
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
| 2015 | 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
Main results already published
Date of protocol fixation
| 2014 | Year | 07 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 09 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 09 | Month | 10 | Day |
Last modified on
| 2016 | Year | 04 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017575
