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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000024792
Receipt No. R000028524
Scientific Title Study for utility of fecal microbiota transplantation for graft-versus-host disease after allogeneic hematopoietic stem cell transplantation.
Date of disclosure of the study information 2016/11/11
Last modified on 2018/11/20

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Basic information
Public title Study for utility of fecal microbiota transplantation for graft-versus-host disease after allogeneic hematopoietic stem cell transplantation.
Acronym GVHDFMT
Scientific Title Study for utility of fecal microbiota transplantation for graft-versus-host disease after allogeneic hematopoietic stem cell transplantation.
Scientific Title:Acronym 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
1st name
Middle name
Last name Hirotsugu Imaeda
Organization Shiga University of Medical Science
Division name Division of Gastroenterology, Department of Medicine
Zip code
Address Setatsukinowa, Otsu
TEL 077-548-2217
Email imaeda@belle.shiga-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hirotsugu Imaeda
Organization Shiga University of Medical Science
Division name Division of Gastroenterology, Department of Medicine
Zip code
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)

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
2016 Year 11 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 Enrolling by invitation
Date of protocol fixation
2016 Year 11 Month 11 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000028524

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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