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 |
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.
Safety evaluation study of frozen FMT capsules for acute GVHD of gut in allo-SCT
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.
Safety evaluation study of frozen FMT capsules for acute GVHD of gut in allo-SCT
Japan |
Steroid resistant/dependent acute graft-versus-host disease of gut after allogeneic hematopoietic stem cell transplantation or donor lymphocyte infusion
Medicine in general | Hematology and clinical oncology |
Others
NO
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.
Safety
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.
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Other |
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.
Not applicable |
Not applicable |
Male and Female
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.
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.
6
1st name | |
Middle name | |
Last name | Kazuhiko Kakihana |
Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
Hematology division
3-18-22 Honkomagome, Bunkyo-ku, Tokyo 113-8677, Japan
+81-3-3823-2101
kakihana@cick.jp
1st name | |
Middle name | |
Last name | Kazuhiko Kakihana |
Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
Hematology division
3-18-22 Honkomagome, Bunkyo-ku, Tokyo 113-8677, Japan
+81-3-3823-2101
kakihana@cick.jp
Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
Self funding
NO
2015 | Year | 12 | Month | 25 | Day |
Unpublished
Enrolling by invitation
2015 | Year | 12 | Month | 02 | Day |
2015 | Year | 12 | Month | 07 | Day |
2015 | Year | 12 | Month | 03 | Day |
2017 | Year | 06 | Month | 06 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023148