UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020091 |
|---|---|
| Receipt number | R000023190 |
| Scientific Title | Efficacy of fecal microbiota transplantation for steroid resistant/ dependent acute graft-versus-host disease of gut, a phase II trial. |
| Date of disclosure of the study information | 2015/12/25 |
| Last modified on | 2019/11/03 20:39:54 |
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Basic information
Public title
Efficacy of fecal microbiota transplantation for steroid resistant/ dependent acute graft-versus-host disease of gut, a phase II trial.
Acronym
Efficacy of FMT for acute GVHD of gut
Scientific Title
Efficacy of fecal microbiota transplantation for steroid resistant/ dependent acute graft-versus-host disease of gut, a phase II trial.
Scientific Title:Acronym
Efficacy of FMT for acute GVHD of gut
Region
| Japan |
Condition
Condition
Steroid resistant/dependent acute graft-versus-host disease of gut after allogeneic hametopoietic stem cell transplantation or donor lymphocyte infusion
Classification by specialty
| Medicine in general | Hematology and clinical oncology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of efficacy of fecal microbiota transplantation for steroid resistant/dependent graft-versus-host disease of gut
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Overall response rate (complete response + partial response) on 28 days after the last FMT.
Key secondary outcomes
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
1) FMT will be started soon after meeting inclusion criteria.
2) Patient who dose not show sufficient response without severe (grade 3 or higher) adverse events can be offered another course of FMT between 7-14 days after prior FMT. The maximum treatment cycles: 2.
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 after allo-SCT, or DLI.
2)Gut aGVHD does not improve within 5 days after initial steroid therapy (1-2 mg/kg of methylprednisolone), or progresses 3 days after initial steroid therapy (steroid-resistant case). Steroid dose can hardly be reduced because of the exacerbation of gut aGVHD (steroid-dependent case).
3) Patients with other comorbid enteropathy can also be enrolled when gut aGVHD is considered as a main cause of their symptoms.
4) Performance status (PS) 0-2 (exclusion: poor PS due to gut aGVHD)
5) Obtained written informed consent from both patient and FMT donor.
Key exclusion criteria
1) Patients who received other systemic therapy, or higher dose of steroid (>2 mg/kg of mPSL) for their aGVHD (exclusion: the use of immunosuppressants for the prophylaxis of GVHD, or topical steroid).
2) Steroid sensitive aGVHD.
3) Progressive aGVHD of skin or liver after steroid therapy.
4) Uncontrollable infection.
5) Patients symptoms are considered to be caused mainly by enteropathy other than gut aGVHD.
6) PS: 3 or higher.
7) Inadequate condition judged by primary physician.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Kazuhiko |
| Middle name | |
| Last name | Kakihana |
Organization
Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
Division name
Hematology division
Zip code
113-8677
Address
Bunkyo-ku
TEL
+81445559340
kakihana@cick.jp
Public contact
Name of contact person
| 1st name | Kazuhiko |
| Middle name | |
| Last name | Kakihana |
Organization
Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
Division name
Hematology division
Zip code
113-8677
Address
3-18-22 Honkomagome, Bunkyo-ku, Tokyo 113-8677, Japan
TEL
+81-3-3823-2101
Homepage URL
kakihana@cick.jp
Sponsor or person
Institute
Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
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
Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
Address
3-18-22 Honkomagome, Bunkyo-ku, Tokyo 113-8677, Japan
Tel
03-3823-2101
rinri@cick.jp
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 | 12 | Month | 25 | 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
17
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
| 2015 | Year | 12 | Month | 02 | Day |
Date of IRB
| 2015 | Year | 12 | Month | 02 | Day |
Anticipated trial start date
| 2015 | Year | 12 | Month | 12 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 12 | Month | 07 | Day |
Last modified on
| 2019 | Year | 11 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023190
| 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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| Registered date | File name |
