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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000034001
Receipt No. 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 2019/03/31

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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
Email 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
Email k-okahara@juntendo.ac.jp

Sponsor
Institute Juntendo Universuty
Institute
Department

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
Email 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
2019 Year 03 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038764

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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