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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000027123
Receipt No. 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

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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
Email 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
Email motoi.uchino@nifty.ne.jp

Sponsor
Institute Hyogo College of Medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027364

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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