UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049692 |
|---|---|
| Receipt number | R000056572 |
| Scientific Title | Basic Research on Microbiome Bank for Manufacturing and Management of Standardized Safe FMT Suspension |
| Date of disclosure of the study information | 2022/12/05 |
| Last modified on | 2022/12/05 12:09:01 |
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Basic information
Public title
Basic Research on Microbiome Bank for Manufacturing and Management of Standardized Safe FMT Suspension
Acronym
Basic Research on Microbiome Bank
Scientific Title
Basic Research on Microbiome Bank for Manufacturing and Management of Standardized Safe FMT Suspension
Scientific Title:Acronym
Basic Research on Microbiome Bank
Region
| Japan |
Condition
Condition
Disorders Associated With Dysbiosis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To promote basic research on microbiome bank to manufacture and manage standardized and safe FMT suspension.
Basic objectives2
Safety,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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) healthy subjects aged >= 18 years at the time of informed consent;
(2) Those who are able to donate regularly.
(3) Those who are able to undergo regular interviews and screening tests(blood test, stool test, saliva test).
(4) Those who are judged to be eligible in the interview about their health status, medical history, treatment history, vaccination history, and history of high-risk behavior.
(5) Those who have the ability to give consent and can obtain written consent of their own free will.
Key exclusion criteria
(1) Suspected infection or carriage of viruses, bacteria, or parasites with the following pathogenicity:
Hepatitis A virus, Hepatitis B virus, Hepatitis C virus, Hepatitis E virus, HIV-1, 2, HTLV-1, Cytomegaloviruses, EB virus, Lues, M. tuberculosis, Clostridioides difficile, Enterohemorrhagic E. coli (O-157), enteroaggregative Escherichia coli (EAEC), Enteropathogenic E. coli (EPEC), Enterotoxigenic E. coli (ETEC), Shiga toxin-producing E. coli (STEC), enteroinvasive Escherichia coli (EIEC), Salmonella, Shigella, Yersinia, Campylobacter, Vibrio parahaemolyticus, Vibrio cholerae, Vibrio vulnificus, Pregenomonas shigeloides, Drug-resistant bacteria, Adenovirus, Norovirus, Rotavirus, Astrovirus, Sapovirus, SARS-CoV-2, Parasites (Strongyloides stercoralis, Giardia lamblia, Cryptosporidium, Entamoeba histolytica, Cyclospora, and other oocysts and parasites)
(2) Those who deviated from the reference values of general peripheral blood test, creatinine, C-reactive protein, AST, ALT, ALP, total bilirubin, and albumin in blood test.
(3) Those who have a positive fecal blood test result from a fecal hemoglobin test.
(4) Persons deemed unsuitable as research subjects by the principal (sub) investigator.
Target sample size
50
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
| 2022 | Year | 12 | Month | 05 | 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
Open public recruiting
Date of protocol fixation
| 2022 | Year | 06 | Month | 24 | Day |
Date of IRB
| 2022 | Year | 06 | Month | 17 | Day |
Anticipated trial start date
| 2022 | Year | 06 | Month | 24 | Day |
Last follow-up date
| 2024 | 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
| 2022 | Year | 12 | Month | 05 | Day |
Last modified on
| 2022 | Year | 12 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056572
| 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 |
