UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020067 |
|---|---|
| Receipt number | R000023148 |
| Scientific Title | Safety of fecal microbiota transplantation using frozen, encapsulated inoculum for steroid resistant/dependent acute graft-versus-host disease of gut in allogeneic hematopoietic stem cell transplantation: A pilot study. |
| Date of disclosure of the study information | 2015/12/25 |
| Last modified on | 2017/06/06 17:47:59 |
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Basic information
Public title
Safety of fecal microbiota transplantation using frozen, encapsulated inoculum for steroid resistant/dependent acute graft-versus-host disease of gut in allogeneic hematopoietic stem cell transplantation: A pilot study.
Acronym
Safety evaluation study of frozen FMT capsules for acute GVHD of gut in allo-SCT
Scientific Title
Safety of fecal microbiota transplantation using frozen, encapsulated inoculum for steroid resistant/dependent acute graft-versus-host disease of gut in allogeneic hematopoietic stem cell transplantation: A pilot study.
Scientific Title:Acronym
Safety evaluation study of frozen FMT capsules for acute GVHD of gut in allo-SCT
Region
| Japan |
Condition
Condition
Steroid resistant/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 safety of fecal microbiota transplantation using frozen, encapsulated inoculum in transplant patients who developed steroid resistant/dependent acute graft-versus-host disease of gut and have a risk for the insertion of elemental diet tube.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Safety of fecal microbiota transplantation using orally administered capsules.
All adverse events which newly occurr or progress within 1 week after each FMT are evaluated for the safety of FMT, and are graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
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 using frozen, encapsulated inoculum, will be started soon after meeting inclusion criteria.
2) The minimum dose of FMT: capsules prepared from 30 grams of donor's feces. There is no upper limit.
3) Patient who did not show sufficient response without any severe (grade 3 or higher) adverse events can be offered another course of FMT between 3 and 10 days after prior FMT.
The maximum treatment cycles: 4.
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, steroid-resistant case), or steroid dose can hardly be reduced less than 0.5 mg/kg of mPSL 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) Patients with a risk for the insertion of ED tube (e.g. severe thrombocytopenia).
6) 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 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) With a risk of aspiration.
8) Inadequate condition judged by primary physician.
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuhiko Kakihana |
Organization
Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
Division name
Hematology division
Zip code
Address
3-18-22 Honkomagome, Bunkyo-ku, Tokyo 113-8677, Japan
TEL
+81-3-3823-2101
kakihana@cick.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuhiko Kakihana |
Organization
Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
Division name
Hematology division
Zip code
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
Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
Organization
Division
Category of Funding Organization
Self funding
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
| 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
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
| 2015 | Year | 12 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 12 | Month | 07 | Day |
Last follow-up date
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 | 03 | Day |
Last modified on
| 2017 | Year | 06 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023148
