UMIN-ICDR Clinical Trial

BACK TOP
UMIN-ICDR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000015115
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email kakihana@cick.jp

Sponsor
Institute Tokyo Metropolitan Cancer and Infectious diseases Center, Komagome Hospital
Institute
Department

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
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 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
URL(English) https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000017575

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.