UMIN-CTR Clinical Trial

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
Email	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
Email	kakihana@cick.jp

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

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023190