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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000018601
Receipt No. R000019616
Scientific Title Intestinal Bacteria Biofilms and Gastrointestinal diseases
Date of disclosure of the study information 2015/08/11
Last modified on 2019/06/19

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Basic information
Public title Intestinal Bacteria Biofilms and Gastrointestinal diseases
Acronym Intestinal Bacteria Biofilms and Gastrointestinal diseases
Scientific Title Intestinal Bacteria Biofilms and Gastrointestinal diseases
Scientific Title:Acronym Intestinal Bacteria Biofilms and Gastrointestinal diseases
Region
Japan

Condition
Condition intestinal disease
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluated the relationship between bacterial mucosal biofilms and intestinal disease
Basic objectives2 Others
Basic objectives -Others to make the analysis methods of mucosal biofilms
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes To make the profile of mucosal biofilms using 16Sr RNA analysis
Key secondary outcomes comparison of mucosal biofilms: mucosa, biopsy, polypectomy, ESD, surgical resection samples

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
20 years-old <=
Age-upper limit
90 years-old >=
Gender Male and Female
Key inclusion criteria patients who need to colonoscopy examinations
Key exclusion criteria patients who has risks against colonoscopy examinations; ileus, perforation of intestine.
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroshi Matsumoto
Organization Kawasaki Medical School
Division name Division of Gastroenterology
Zip code
Address Matsushima577, Kurashiki city, Okayama
TEL 0864621111
Email hmatsumoto0311@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Hiroshi Matsumoto
Organization Kawasaki Medical School
Division name Division of Gastroenterology
Zip code
Address Matsushima577, Kurashiki city, Okayama
TEL 0864621111
Homepage URL
Email hmatsumoto0311@gmail.com

Sponsor
Institute Kawasaki Medical School
Institute
Department

Funding Source
Organization Kawasaki Medical School
Organization
Division
Category of Funding Organization Other
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 川崎医科大学(岡山)、杏林大学(東京)

Other administrative information
Date of disclosure of the study information
2015 Year 08 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
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 Enrolling by invitation
Date of protocol fixation
2015 Year 08 Month 01 Day
Date of IRB
2015 Year 05 Month 23 Day
Anticipated trial start date
2015 Year 10 Month 01 Day
Last follow-up date
2023 Year 06 Month 25 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information have a plan to report the evaluation in 50 patients

Management information
Registered date
2015 Year 08 Month 08 Day
Last modified on
2019 Year 06 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019616

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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