UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034001 |
|---|---|
| Receipt number | R000038764 |
| Scientific Title | Enterobacterial analysis as the biomarker for the inflammatory bowel disease |
| Date of disclosure of the study information | 2018/09/03 |
| Last modified on | 2024/06/05 17:57:21 |
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Basic information
Public title
Enterobacterial analysis as the biomarker for the inflammatory bowel disease
Acronym
Enterobacterial analysis as the biomarker for the inflammatory bowel disease
Scientific Title
Enterobacterial analysis as the biomarker for the inflammatory bowel disease
Scientific Title:Acronym
Enterobacterial analysis as the biomarker for the inflammatory bowel disease
Region
| Japan |
Condition
Condition
Inflammatory bowel disease
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
It is noninvasive and is established the biomarker with a little patient's share of medical expenses
Basic objectives2
Others
Basic objectives -Others
identify the entrobacteria
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We compare laboratory data, clinical conditions and endoscopic findings one-year after entry with patient' enterobacteria, and we identify the enterobacteria which correlate with clinical conditions and endoscopic findings.
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
Prevention
Type of intervention
| Other |
Interventions/Control_1
Collection the fecal samples
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
IBD patients
More than 20 years old
Key exclusion criteria
1. Patients with severe situation
2. patients with pregnancy
3. Patients taking anticoagulant.
4. Patient who doctors realize inappropriate for this study.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Dai |
| Middle name | |
| Last name | Ishikawa |
Organization
Juntendo University
Division name
Gastroenterology
Zip code
113-8421
Address
bunkyo-ku hongo 2-1-1
TEL
0338133111
Dai@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Koki |
| Middle name | |
| Last name | Okahara |
Organization
Juntendo University
Division name
Gastroenterology
Zip code
113-8421
Address
bunkyo-ku hongo 2-1-1
TEL
0338133111
Homepage URL
k-okahara@juntendo.ac.jp
Sponsor or person
Institute
Juntendo Universuty
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Juntendo university hospital
Address
2-1-1 Hongo Bunkyoku
Tel
0338133111
kenkyu5858@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
| 2018 | Year | 09 | Month | 03 | 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
| 2017 | Year | 09 | Month | 22 | Day |
Date of IRB
| 2017 | Year | 09 | Month | 22 | Day |
Anticipated trial start date
| 2017 | Year | 09 | Month | 22 | Day |
Last follow-up date
| 2020 | 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
| 2018 | Year | 09 | Month | 03 | Day |
Last modified on
| 2024 | Year | 06 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038764
