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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000019486
Receipt No. R000022519
Scientific Title Enterobacterial analysis for the precise medical care (precision medicine) for diabetes, non-alcoholic lipid liver disease / non-alcoholicity fat hepatitis, inflammatory bowel disease, and irritable bowel syndrome.
Date of disclosure of the study information 2015/12/01
Last modified on 2018/07/30

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Basic information
Public title Enterobacterial analysis for the precise medical care (precision medicine) for diabetes, non-alcoholic lipid liver disease / non-alcoholicity fat hepatitis, inflammatory bowel disease, and irritable bowel syndrome.
Acronym Enterobacterial analysis for the precise medical care (precision medicine).
Scientific Title Enterobacterial analysis for the precise medical care (precision medicine) for diabetes, non-alcoholic lipid liver disease / non-alcoholicity fat hepatitis, inflammatory bowel disease, and irritable bowel syndrome.
Scientific Title:Acronym Enterobacterial analysis for the precise medical care (precision medicine).
Region
Japan

Condition
Condition diabetes, non-alcoholic lipid liver disease / non-alcoholicity fat hepatitis, inflammatory bowel disease (ulcerative colitis, Crohn's disease), irritable bowel disease, neuroimmune disease, lung cancer, esophageal cancer, gastric cancer, colorectal cancer
Classification by specialty
Medicine in general Gastroenterology Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The patients of diabetes, non-alcoholic lipid liver disease / non-alcoholicity fat hepatitis, inflammatory bowel disease, irritable bowel disease, neuroimmune disease, lung cancer, esophageal cancer, gastric cancer, colorectal cancer have been recently increased and cause the increase of medical costs. However, as the pathogenesis and has not been clear, the primary treatment has not been established.
On the other hand, enteric flora has been reported to be involved to the pathogenesis of various disease. But the perspectives have not shown yet.
In this study, we aimed to elucidate the pathogenesis and show the contribution of the treatment against these diseases controlling enteric flora.
Basic objectives2 Bio-availability
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Tendency of the enterobacterial flora of each disease compared to healthy control.
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
15 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria The patients who are diagnosed as follows:
1) Diabetes patients diagnosed based on the diagnostic criteria of the Japanese diabetes society 2015
2) NASH/NAFLD patients who are diagnosed based on the Medical treatment guide 2010 of NASH, NAFLD of Japanese liver society guidelines
3) IBS patients who are diagnosed based on ROME III criteria.
4) The patients diagnosed as ulcerative colitis and Crohn's disease based on the criteria of Japanese Ministry of Health, Specific disease intractable inflammation-related intestinal tract disorder research group.
Key exclusion criteria 1) Re-registration example to the examination
2) The patients with surgical operation within 12 weeks
3) In addition, the patient who judged an arrangement to the examination if the medical attendant was inappropriate
4) The patients who have stoma.
Target sample size 175

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yuji Naito
Organization Kyoto Prefectural University of Medicine
Division name Molecular Gastroenterology and Hepatology
Zip code
Address 465 Kajiicho Hirokoji, Kawaramachidori, Kamigyo-ku, Kyoto, Japan
TEL 075-251-5519
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 Medicinea
Division name Molecular Gastroenterology and Hepatology
Zip code
Address 465 Kajiicho Hirokoji, Kawaramachidori, Kamigyo-ku, Kyoto, Japan
TEL 075-251-5519
Homepage URL
Email k-uchi@koto.kpu-m.ac.jp

Sponsor
Institute Kyoto Prefectural University of Medicine
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization Japanese Governmental office
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 京都府立医科大学附属病院

Other administrative information
Date of disclosure of the study information
2015 Year 12 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 Open public recruiting
Date of protocol fixation
2015 Year 10 Month 30 Day
Date of IRB
Anticipated trial start date
2015 Year 12 Month 01 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
2020 Year 03 Month 31 Day
Date trial data considered complete
2020 Year 06 Month 30 Day
Date analysis concluded
2020 Year 07 Month 31 Day

Other
Other related information 1) Sample collecting
Stool collection kit (TechnoSuruga Laboratory Co., Ltd.) is used to collect samples. The kit was given to the patients and healthy controls when they agreed to participate this study. The envelope will be also given and after sample collection, patients put the kit into the envelope and post it to TechnoSuruga Laboratory. The analysis of enteric flora will be performed by T-RFLP, metagenomics, PCR, and germ culture.
2) The items to evaluate patients
DM: FBS, HbA1c, and complications
NASH/NAFLD: liver function (AST, ALT etc), the index of hepatic fibrosis
IBS: the score such as IBS-SSS
UC: endoscopic findings (Mayo score), clinical activity index (Lichtiger score), inflammatory index of blood examination.

Management information
Registered date
2015 Year 10 Month 24 Day
Last modified on
2018 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=R000022519

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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