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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000020067
Receipt No. 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

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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
Email 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
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023148

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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