UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027123 |
|---|---|
| Receipt number | R000027364 |
| Scientific Title | The alteration of bacterial flora during restorative proctocolectomy and association between flora and ulcerative colotis related complication. |
| Date of disclosure of the study information | 2017/05/01 |
| Last modified on | 2017/04/25 14:31:20 |
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Basic information
Public title
The alteration of bacterial flora during restorative proctocolectomy and association between flora and ulcerative colotis related complication.
Acronym
association between bacterial flora and post-operative complications.
Scientific Title
The alteration of bacterial flora during restorative proctocolectomy and association between flora and ulcerative colotis related complication.
Scientific Title:Acronym
association between bacterial flora and post-operative complications.
Region
| Japan |
Condition
Condition
ulcerative colitis
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Ulcerative colitis related complications which include pouchitis can be developped even after restorative proctocolectomy. The aim of this study is to clarify the associations of bacterial flora.
Basic objectives2
Others
Basic objectives -Others
Alteration of bacterial flora
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Compare the bacterial flora during restorative proctocolectomy and peri-treatment for pouchitis.
Key secondary outcomes
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
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients who developed pouchitis after restorative proctocolectomy.
Key exclusion criteria
Patients
without pouchitis.
with other infectious disease.
without consent.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Motoi Uchino |
Organization
Hyogo College of Medicine
Division name
Inflammatory Bowel Disease
Zip code
Address
1-1 Mukogawacho, Nishinomiya, Hyogo, Japan
TEL
0798-45-6371
motoi.uchino@nifty.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Motoi Uchino |
Organization
Hyogo College of Medicine
Division name
Inflammatory Bowel Disease
Zip code
Address
1-1 Mukogawacho, Nishinomiya, Hyogo, Japan
TEL
0798-45-6371
Homepage URL
motoi.uchino@nifty.ne.jp
Sponsor or person
Institute
Hyogo College of Medicine
Institute
Department
Personal name
Funding Source
Organization
Hyogo College of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
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
兵庫医科大学（兵庫県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 05 | Month | 01 | 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
Terminated
Date of protocol fixation
| 2017 | Year | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2022 | Year | 12 | Month | 31 | Day |
Other
Other related information
before observation
Management information
Registered date
| 2017 | Year | 04 | Month | 25 | Day |
Last modified on
| 2017 | 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=R000027364
