UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056258 |
|---|---|
| Receipt number | R000064276 |
| Scientific Title | Study on Gut Microbiota as Biomarkers in Ulcerative Colitis |
| Date of disclosure of the study information | 2024/11/25 |
| Last modified on | 2024/11/25 08:23:42 |
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Basic information
Public title
Study on Gut Microbiota as Biomarkers in Ulcerative Colitis
Acronym
Study on Gut Microbiota as Biomarkers in Ulcerative Colitis
Scientific Title
Study on Gut Microbiota as Biomarkers in Ulcerative Colitis
Scientific Title:Acronym
Study on Gut Microbiota as Biomarkers in Ulcerative Colitis
Region
| Japan |
Condition
Condition
ulcerative colitis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We analyzed the gut microbiota of UC patients at various levels of disease severity and compared it before and after treatment to identify gut bacteria or microbiota profiles that may be useful for evaluating treatment outcomes in UC patients.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Comparison of gut microbiota in feces before and after treatment
Key secondary outcomes
Correlation analysis between gut microbiota and disease activity
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. Individuals aged 18 years or older at the time of obtaining consent.
2. Individuals who, after receiving a thorough explanation of this study and fully understanding its details, provided written consent based on their own free will.
Key exclusion criteria
Individuals deemed unsuitable as research subjects by the principal investigator.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Kei |
| Middle name | |
| Last name | Nomura |
Organization
Juntendo University
Division name
Department of Gastroenterology
Zip code
113-8421
Address
2-1-1 Hongo, Bunkyo-ku, Tokyo
TEL
03-3813-3111
ke-nomura@jutendo.ac.jp
Public contact
Name of contact person
| 1st name | Kei |
| Middle name | |
| Last name | Nomura |
Organization
Juntendo University
Division name
Department of Gastroenterology
Zip code
113-8421
Address
2-1-1 Hongo, Bunkyo-ku, Tokyo
TEL
03-3813-3111
Homepage URL
ke-nomura@jutendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Funding Source
Organization
Japan Foundation for Applied Enzymology
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Juntendo University
Address
2-1-1 Hongo, Bunkyo-ku, Tokyo
Tel
03-3813-3111
igakubu.rinri1@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
| 2024 | Year | 11 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 11 | Month | 18 | Day |
Date of IRB
| 2024 | Year | 11 | Month | 18 | Day |
Anticipated trial start date
| 2024 | Year | 11 | Month | 18 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
After obtaining consent from patients with ulcerative colitis, blood and fecal samples will be collected for microbiota analysis, including 16S rDNA-based metagenomic analysis and shotgun metagenomic analysis. Metabolome analysis will also be conducted.
Management information
Registered date
| 2024 | Year | 11 | Month | 25 | Day |
Last modified on
| 2024 | Year | 11 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064276
