UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049982 |
|---|---|
| Receipt number | R000056926 |
| Scientific Title | Basic research on the FMT suspension for microbiome regeneration |
| Date of disclosure of the study information | 2023/01/06 |
| Last modified on | 2023/01/06 17:31:12 |
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Basic information
Public title
Basic research on the FMT suspension for microbiome regeneration
Acronym
Basic research on the FMT suspension
Scientific Title
Basic research on the FMT suspension for microbiome regeneration
Scientific Title:Acronym
Basic research on the FMT suspension for microbiome regeneration
Region
| Japan |
Condition
Condition
Disorders Associated With Dysbiosis
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this project is to promote basic research to find a suitable FMT suspension for safer and more effective fecal microbiota transplantation in the stool for microbiome regeneration.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
-
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Persons who are 20 years of age or older at the time of obtaining consent.
(2) After receiving a thorough explanation of the research, the subject of the research must fully understand and give his/her free and voluntary written consent to participate in this research. (3) Persons who have given written consent to participate in this study after receiving sufficient explanation.
Key exclusion criteria
(1) Those who have used oral antibacterial agents within 2 weeks of stool specimen collection
(2) Those who currently have an underlying disease requiring treatment
(3) Other subjects who are deemed inappropriate as research subjects by the principal investigator.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Dai |
| Middle name | |
| Last name | Ishikawa |
Organization
Juntendo University Hospital
Division name
Department of Gastroenterology
Zip code
113-8431
Address
3-1-3 Hongo,Bunkyo-ku,Tokyo
TEL
03-3813-3111
dai@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Dai |
| Middle name | |
| Last name | Ishikawa |
Organization
Juntendo University Hospital
Division name
Department of Gastroenterology
Zip code
113-8431
Address
3-1-3 Hongo,Bunkyo-ku,Tokyo
TEL
03-3813-3111
Homepage URL
dai@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Funding Source
Organization
Metagen Therapeutics, Inc.,
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee Faculty of Medicine, Juntendo University
Address
3-1-3 Hongo,Bunkyo-ku,Tokyo
Tel
03-5802-1584
hongo-rinri@juntendo.ac.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
| 2023 | Year | 01 | Month | 06 | 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
| 2022 | Year | 05 | Month | 02 | Day |
Date of IRB
| 2022 | Year | 05 | Month | 02 | Day |
Anticipated trial start date
| 2022 | Year | 05 | Month | 02 | Day |
Last follow-up date
| 2025 | 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
| 2023 | Year | 01 | Month | 06 | Day |
Last modified on
| 2023 | Year | 01 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056926
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
