UMIN-ICDS 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

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 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


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

Value
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