UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016673 |
|---|---|
| Receipt number | R000019350 |
| Scientific Title | Establishment of a new diagnostic classification for UC patients using the intestinal flora pattern analysis |
| Date of disclosure of the study information | 2015/03/02 |
| Last modified on | 2016/04/02 19:17:56 |
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Basic information
Public title
Establishment of a new diagnostic classification for UC patients using the intestinal flora pattern analysis
Acronym
Establishment of a new diagnostic classification for UC patients using the intestinal flora pattern analysis
Scientific Title
Establishment of a new diagnostic classification for UC patients using the intestinal flora pattern analysis
Scientific Title:Acronym
Establishment of a new diagnostic classification for UC patients using the intestinal flora pattern analysis
Region
| Japan |
Condition
Condition
Ulcerative colitis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate associations between various clinical classifications and fecal microbiota profiles in UC patients
Basic objectives2
Others
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
To identify characteristic fecal microbiota profiles in UC patients
Key secondary outcomes
The association between clinical characteristic (disease activity, disease duration, extent of colitis, clinical course etc.) and fecal microbiota profile
The association between treatment responsiveness and fecal microbiota profile
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
| 15 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with ulcerative colitis
Key exclusion criteria
Patient who were judged to be exclusive by investigators
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Norihito Watanabe |
Organization
Tokai University Hachioji Hospital
Division name
Division of Gastroenterology
Zip code
Address
1838, Ishikawa-machi, Hachioji-shi, Tokyo
TEL
0426-39-1111
norihito@is.icc.u-tokai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hitoshi Ichikawa |
Organization
Tokai University Hachioji Hospital
Division name
Division of Gastroenterology
Zip code
Address
1838, Ishikawa-machi, Hachioji-shi, Tokyo
TEL
0426-39-1111
Homepage URL
ichikawa.hitoshi@plum.plala.or.jp
Sponsor or person
Institute
Tokai University Hachioji Hospital
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
Saitama Medical University Hospital
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
| 2015 | Year | 03 | Month | 02 | 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
| 2014 | Year | 10 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 11 | Month | 08 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The association between clinical characteristic (disease activity, disease duration, extent of colitis, clinical course etc.) and fecal microbiota profile
The association between treatment responsiveness and fecal microbiota profile
Management information
Registered date
| 2015 | Year | 03 | Month | 01 | Day |
Last modified on
| 2016 | Year | 04 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019350
