UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024145 |
|---|---|
| Receipt number | 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 | 2019/09/29 14:08:51 |
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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 | Yuji |
| Middle name | |
| Last name | Naito |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
602-8566
Address
Kamigyo-ku
TEL
0752515519
ynaito@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | Kazuhiko |
| Middle name | |
| Last name | Uchiyama |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
602-8566
Address
Kamigyo-ku
TEL
0752515519
Homepage URL
k-uchi@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine
Institute
Department
Personal name
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
Kyoto Prefectural University of Medicine
Address
465, Kajii-cho, Kawaramachi-Hirokoji
Tel
0752515519
mariko-k@koto.kpu-m.ac.jp
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
| 2019 | Year | 09 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027797
