UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027053 |
|---|---|
| Receipt number | R000031012 |
| Scientific Title | Association between pouchitis and feacal bacterial flora after restorative proctocolectomy. |
| Date of disclosure of the study information | 2017/06/01 |
| Last modified on | 2017/04/18 20:23:43 |
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Basic information
Public title
Association between pouchitis and feacal bacterial flora after restorative proctocolectomy.
Acronym
Pouchitis and feacal bacteria
Scientific Title
Association between pouchitis and feacal bacterial flora after restorative proctocolectomy.
Scientific Title:Acronym
Pouchitis and feacal bacteria
Region
| Japan |
Condition
Condition
ulcerative colitis
adenomatous polyposis coli
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Pouchitis often develop even after restorative proctocolectomy in patients with ulcerative colitis. Almost patients with pouchitis respond to the treatment with antibiotics. Therfore, feacal bacterias are suggested as the trigger of pouchitis. Herein, we investigate the association between pouchitis and feacal bacterial flora.
Basic objectives2
Others
Basic objectives -Others
pilot study
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase I
Assessment
Primary outcomes
The alteration in fecal bacterial flora during surgical course and 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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The consent was obteined in surgical patients.
Key exclusion criteria
Age under 18 yrs.
Patients without consent.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Motoi Uchino |
Organization
Hyogo college of medicine
Division name
department of Inflammatory Bowel disease
Zip code
Address
1-1 Mukogawacho, Nishinomiya, Hyogo, Japan
TEL
0798-45-6371
uchino2s@hyo-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Motoi Uchino |
Organization
Hyogo College of Medicine
Division name
Department of Inflammatory Bowel Disease
Zip code
Address
1-1 Mukogawacho, Nishinomiya, Hyogo, Japan
TEL
0798-45-6371
Homepage URL
uchino2s@hyo-med.ac.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
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
| 2017 | Year | 06 | 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
Preinitiation
Date of protocol fixation
| 2017 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 06 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We evaluate and compare the alterations of feacal bacterial flora during surgery and treatment for pouchitis.
Management information
Registered date
| 2017 | Year | 04 | Month | 18 | Day |
Last modified on
| 2017 | Year | 04 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031012
| 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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