UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study for utility of fecal microbiota transplantation for graft-versus-host disease after allogeneic hematopoietic stem cell transplantation.
Title of the study (Brief title)	GVHDFMT
Region	Japan

Condition
Condition	graft-versus-host disease after allogeneic hematopoietic stem cell
Classification by specialty	Gastroenterology Hematology and clinical oncology Blood transfusion
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We examine a utility eight weeks after FMT for GVHD after allogeneic hematopoietic stem cell transplantation. We think about whether FMT may become the choice of GVHD after new allogeneic hematopoietic stem cell transplantation of GVHD.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	A utility eight weeks after FMT for GVHD after allogeneic hematopoietic stem cell transplantation.
Key secondary outcomes	A safety eight weeks after FMT for GVHD after allogeneic hematopoietic stem cell transplantation.

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	Maneuver
Interventions/Control_1	FMT
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	20 years-old <=
Age-upper limit	65 years-old >
Gender	Male and Female
Key inclusion criteria	Presence or absence of primary therapy and steroid-resistant or steroid-dependent presence do not matter. (2) Age is one younger than 65 years 20 years old or older. (3) Performance status (PS) is 0, 1, 2 patients. (4) About participation in this study, as for the person. It can be a provider (donor) an agreement is obtained from one, following. (1) It is a person within the third degree from a study participant (recipients) (2) It is a person until 65 years old 20 years old or older (3) The one that can have you offer feces 200 g or more on the day of transplantation
Key exclusion criteria	(1) A blood test: HIV, HTLV-1, syphilis, liver dysfunction, hepatitis A, hepatitis B, hepatitis C, cytomegalovirus, EB virus, amoebic dysentery (2) A feces examination: Helicobacter pylori, Yersinia, Campylobactor, dysentery, Salmonella, hemorrhagic enteropathic E.coli, rotavirus, adenovirus, norovirus, parasitic worm screening, ova of parasites screening, Clostridium difficile (CD toxin A/B)
Target sample size	10

Research contact person
Name of lead principal investigator	Hirotsugu Imaeda
Organization	Shiga University of Medical Science
Division name	Division of Gastroenterology, Department of Medicine
Address	Setatsukinowa, Otsu
TEL	077-548-2217
Email	imaeda@belle.shiga-med.ac.jp

Public contact
Name of contact person	Hirotsugu Imaeda
Organization	Shiga University of Medical Science
Division name	Division of Gastroenterology, Department of Medicine
Address	Setatsukinowa, Otsu
TEL	077-548-2217
Homepage URL	http://www.ninai-sums.jp/study/gastrointestinal-medicine
Email	imaeda@belle.shiga-med.ac.jp

Sponsor
Institute	Shiga University of Medical Science
Institute
Department

Funding Source
Organization	Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization	Japanese Governmental office
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	2016 Year 11 Month 11 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2016 Year 11 Month 11 Day
Anticipated trial start date	2016 Year 11 Month 11 Day
Last follow-up date	2019 Year 03 Month 31 Day
Date of closure to data entry	2019 Year 03 Month 31 Day
Date trial data considered complete	2019 Year 03 Month 31 Day
Date analysis concluded	2019 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 11 Month 10 Day
Last modified on	2018 Year 11 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000028524