UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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.
Title of the study (Brief title)	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	Kazuhiko Kakihana
Organization	Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
Division name	Hematology division
Address	3-18-22 Honkomagome, Bunkyo-ku, Tokyo 113-8677, Japan
TEL	+81-3-3823-2101
Email	kakihana@cick.jp

Public contact
Name of contact person	Kazuhiko Kakihana
Organization	Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
Division name	Hematology division
Address	3-18-22 Honkomagome, Bunkyo-ku, Tokyo 113-8677, Japan
TEL	+81-3-3823-2101
Homepage URL
Email	kakihana@cick.jp

Sponsor
Institute	Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
Institute
Department

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)

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

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2015 Year 12 Month 02 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000023148