UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024743 |
|---|---|
| Receipt number | R000028467 |
| Scientific Title | The analysis of mucosa-associated microbiota in IBD |
| Date of disclosure of the study information | 2016/11/07 |
| Last modified on | 2017/06/19 15:11:06 |
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Basic information
Public title
The analysis of mucosa-associated microbiota in IBD
Acronym
The analysis of mucosa-associated microbiota in IBD
Scientific Title
The analysis of mucosa-associated microbiota in IBD
Scientific Title:Acronym
The analysis of mucosa-associated microbiota in IBD
Region
| Japan |
Condition
Condition
inflammatory bowel disease
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the components of mucosa-associated in IBD
Basic objectives2
Others
Basic objectives -Others
To assess the impact of mucosa-associated microbiota on the pathology of IBD
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
The components of mucosa-associated microbiota and the impact on the pathology of IBD
Key secondary outcomes
The association of mucosa-associated microbiota and treatment history
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
IBD patients who undergoing gastrointestinal endoscopy
Other patients who undergoing gastrointestinal endoscopy
Key exclusion criteria
Patients who reject to participate in this study
Patients with infectious disease that requires notification under the Infectious Diseases Control Law
Patients who are considered to be unsuitable to this study for any other reason
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akira Andoh |
Organization
Shiga University of Medical Science
Division name
Division of Gastroenterology, Department of Medicine
Zip code
Address
Setatsukinowa, Otsu
TEL
077-548-2217
andoh@belle.shiga-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Atsushi Nishida |
Organization
Shiga University of Medical Science
Division name
Division of Gastroenterology, Department of Medicine
Zip code
Address
Setatsukinowa, Otsu
TEL
077-548-2217
Homepage URL
atsuda@belle.shiga-med.ac.jp
Sponsor or person
Institute
Shiga University of Medical Science
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2016 | Year | 11 | Month | 07 | 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
| 2016 | Year | 11 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 11 | Month | 07 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We aim to clarify the structure and function analysis of mucosa-associated microbiota in patients with inflammatory bowel disease.
Management information
Registered date
| 2016 | Year | 11 | Month | 07 | Day |
Last modified on
| 2017 | Year | 06 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028467
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
