UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017103 |
|---|---|
| Receipt number | R000019839 |
| Scientific Title | Analysis of intestinal flora by Genomic analysis in ulcerative colitis patients |
| Date of disclosure of the study information | 2015/04/11 |
| Last modified on | 2023/04/25 15:30:20 |
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Basic information
Public title
Analysis of intestinal flora by Genomic analysis in ulcerative colitis patients
Acronym
Analysis of intestinal flora by Genomic analysis
Scientific Title
Analysis of intestinal flora by Genomic analysis in ulcerative colitis patients
Scientific Title:Acronym
Analysis of intestinal flora by Genomic analysis
Region
| Japan |
Condition
Condition
Ulcerative colitis/Healthy
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Analysis of intestinal flora in ulcerative colitis patients and the families.
Basic objectives2
Others
Basic objectives -Others
Subject background
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Analysis of intestinal flora
Key secondary outcomes
Subject background
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Ulcerative colitis patients and the families
Key exclusion criteria
Nothing particular
Target sample size
140
Research contact person
Name of lead principal investigator
| 1st name | Katsuyuyki |
| Middle name | |
| Last name | Fukuda |
Organization
St. Luke's International Hospital
Division name
Department of Gastroenterology
Zip code
104-8560
Address
9-1, Akashi-cho, Chuo-ku Tokyo 104-8560 Japan
TEL
03-3541-5151
fukukats@luke.ac.jp
Public contact
Name of contact person
| 1st name | Katsuyuki |
| Middle name | |
| Last name | Fukuda |
Organization
St. Luke's International Hospital
Division name
Department of Gastroenterology
Zip code
104-8560
Address
9-1, Akashi-cho, Chuo-ku Tokyo 104-8560 Japan
TEL
03-3541-5151
Homepage URL
fukukats@luke.ac.jp
Sponsor or person
Institute
St. Luke's International Hospital
Institute
Department
Personal name
Funding Source
Organization
Nothing particular
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
TechnoSuruga Laboratory Co., Ltd.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Ethics Committee of St Luke's International Hospital
Address
9-1, Akashi-cho, Chyuo-ku, Tokyo
Tel
03-3541-5151
kenkyukikaku@luke.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
聖路加国際病院
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 04 | Month | 11 | 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
143
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
No longer recruiting
Date of protocol fixation
| 2014 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2014 | Year | 09 | Month | 10 | Day |
Anticipated trial start date
| 2014 | Year | 09 | Month | 10 | Day |
Last follow-up date
| 2023 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2017 | Year | 05 | Month | 01 | Day |
Date analysis concluded
Other
Other related information
Analysis of intestinal flora by genomic analysis
Subject background
Management information
Registered date
| 2015 | Year | 04 | Month | 11 | Day |
Last modified on
| 2023 | Year | 04 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019839
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
