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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000024145
Receipt No. R000027797
Scientific Title Analysis ofgastrointestinal microbiota of inflammatory bowel disease, gastrointestinal carcinoma using samples collected by endoscopy.
Date of disclosure of the study information 2016/11/01
Last modified on 2017/07/30

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Basic information
Public title Analysis ofgastrointestinal microbiota of inflammatory bowel disease, gastrointestinal carcinoma using samples collected by endoscopy.
Acronym Analysis ofgastrointestinal microbiota of inflammatory bowel disease, gastrointestinal carcinoma using samples collected by endoscopy.
Scientific Title Analysis ofgastrointestinal microbiota of inflammatory bowel disease, gastrointestinal carcinoma using samples collected by endoscopy.
Scientific Title:Acronym Analysis ofgastrointestinal microbiota of inflammatory bowel disease, gastrointestinal carcinoma using samples collected by endoscopy.
Region
Japan

Condition
Condition The patients of esophageal cancer, gastric cancer, hepatocellular carcinoma, pancreatic cancer, colorectal cancer, ulcerative colitis, Crohn's disease, intestinal Behcet's disease, Barrett esophagus, gastric adenoma, colorectal adenoma, functional dyspepsia. And healthy subjects who are performed endoscopy.
Classification by specialty
Gastroenterology Hepato-biliary-pancreatic medicine Gastrointestinal surgery
Hepato-biliary-pancreatic surgery Adult
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 We will investigate the pathogenesis of various disease through the analysis of gastrointestinal microbiota.
Basic objectives2 Others
Basic objectives -Others Analysis of the gastrointestinal microbiota
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes The difference of gastrointestinal microbiota between healthy control and each disease.
Key secondary outcomes The correlation between the variation of gastrointestinal microbiota and condition of each disease.

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
75 years-old >=
Gender Male and Female
Key inclusion criteria The patients of esophageal cancer, gastric cancer, hepatocellular carcinoma, pancreatic cancer, colorectal cancer, ulcerative colitis, Crohn's disease, intestinal Behcet's disease, Barrett esophagus, gastric adenoma, colorectal adenoma, functional dyspepsia. And healthy subjects who are performed endoscopy.
Key exclusion criteria The patients with the artificial anus

The patients who underwent the surgery for the intestinal tract within 12 weeks

The patients who received antibiotics within four weeks before registration day

The patients that an agreement is not obtained

The patients that doctor attending judged an arrangement to this study to be inadequate
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yuji Naito
Organization Kyoto Prefectural University of Medicine
Division name Department of Gastroenterology and Hepatology
Zip code
Address 465, Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan
TEL 075-251-5111
Email ynaito@koto.kpu-m.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazuhiko Uchiyama
Organization Kyoto Prefectural University of Medicine
Division name Department of Gastroenterology and Hepatology
Zip code
Address 465, Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan
TEL 075-251-5111
Homepage URL
Email k-uchi@koto.kpu-m.ac.jp

Sponsor
Institute Kyoto Prefectural University of Medicine
Institute
Department

Funding Source
Organization Japan Science and Technology Agency
Organization
Division
Category of Funding Organization Japanese Governmental office
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 京都府立医科大学(京都府)

Other administrative information
Date of disclosure of the study information
2016 Year 11 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 Enrolling by invitation
Date of protocol fixation
2016 Year 11 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 11 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 analyze the population of microbiota in the specimen using 16S rRNA meta genome analysis by a next-generation sequencer (MiSeq).

Management information
Registered date
2016 Year 09 Month 23 Day
Last modified on
2017 Year 07 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027797

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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