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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000020091
Receipt No. R000023190
Scientific Title Efficacy of fecal microbiota transplantation for steroid resistant/ dependent acute graft-versus-host disease of gut, a phase II trial.
Date of disclosure of the study information 2015/12/25
Last modified on 2019/11/03

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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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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