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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000027053
Receipt No. 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

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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
Email 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
Email uchino2s@hyo-med.ac.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

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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031012

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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