UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024792 |
|---|---|
| Receipt number | 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 21:54:09 |
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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
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
imaeda@belle.shiga-med.ac.jp
Sponsor or person
Institute
Shiga University of Medical Science
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028524
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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