UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Safety and efficacy of fecal microbiota transplantation for steroid resistant acute graft-versus-host disease of gut in allogeneic hematopoietic stem cell transplantation
Title of the study (Brief title)	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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Kazuhiko Kakihana
Organization	Tokyo Metropolitan Cancer and Infectious diseases Center, Komagome Hospital
Division name	Hematology division
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	Kazuhiko Kakihana
Organization	Tokyo Metropolitan Cancer and Infectious diseases Center, Komagome Hospital
Division name	Hematology division
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

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Main results already published
Date of protocol fixation	2014 Year 07 Month 28 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017575