UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053473 |
|---|---|
| Receipt number | R000061036 |
| Scientific Title | Safety of fecal microbiota transplantation for steroid-refractory/dependent acute graft-versus-host disease of the gut, a phase I trial |
| Date of disclosure of the study information | 2024/02/01 |
| Last modified on | 2024/01/29 23:49:44 |
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Basic information
Public title
Safety of fecal microbiota transplantation for steroid-refractory/dependent acute graft-versus-host disease of the gut, a phase I trial
Acronym
Safety of FMT for acute gut GVHD
Scientific Title
Safety of fecal microbiota transplantation for steroid-refractory/dependent acute graft-versus-host disease of the gut, a phase I trial
Scientific Title:Acronym
Safety of FMT for acute gut GVHD
Region
| Japan |
Condition
Condition
Steroid refractory/dependent acute graft-versus-host disease of gut after allogeneic hematopoietic 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 the safety of FMT for steroid-refractory/dependent acute graft-versus-host disease of gut
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of adverse events that occurred or worsened within 1 week after 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
| 15 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)Acute GVHD of gut after allo-SCT or DLI.
2) Gut aGVHD that does not improve within 5 days after 1-2 mg/kg of initial steroid therapy (steroid-refracotry) or that can hardly be reduced because of the exacerbation of gut aGVHD (steroid-dependent case).
3) Patients with coexisting non-GVHD enteropathy can also be enrolled when gut aGVHD is considered as a main cause of their symptoms.
4) 15 to 80 years of age at the time of consent.
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) Steroid sensitive aGVHD.
2) Progressive aGVHD, in which affected organ is irrelevant.
3) Uncontrollable infection.
4) Patients symptoms are considered to be caused mainly by enteropathy other than gut aGVHD.
5) PS 3 or higher.
6) Patients at high risk of aspiration.
7) Inadequate condition judged by primary physician.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Taro |
| Middle name | |
| Last name | Tochigi |
Organization
Hamanomachi Hospital
Division name
Department of hematology
Zip code
810-0072
Address
3-3-1 Nagahama, Chuo-ku, Fukuoka City, Fukuoka
TEL
+81927210831
tochigi-t@hamanomachi.jp
Public contact
Name of contact person
| 1st name | Taro |
| Middle name | |
| Last name | Tochigi |
Organization
Hamanomachi hospital
Division name
Department of hematology
Zip code
810-0072
Address
3-3-1 Nagahama, Chuo-ku, Fukuoka City, Fukuoka
TEL
+81927210831
Homepage URL
tochigi-t@hamanomachi.jp
Sponsor or person
Institute
Hamanomachi hospital
Institute
Department
Personal name
Funding Source
Organization
Hamanomachi hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hamanomachi hospital
Address
3-3-1 Nagahama, Chuo-ku, Fukuoka City, Fukuoka
Tel
+81927210831
tochigi-t@hamanomachi.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
| 2024 | Year | 02 | Month | 01 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 12 | Month | 05 | Day |
Date of IRB
| 2023 | Year | 12 | Month | 05 | Day |
Anticipated trial start date
| 2023 | Year | 12 | Month | 05 | Day |
Last follow-up date
| 2033 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 01 | Month | 29 | Day |
Last modified on
| 2024 | Year | 01 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061036
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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