UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019486 |
|---|---|
| Receipt number | 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 | 2022/04/29 10:44:28 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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 | Yuji |
| Middle name | |
| Last name | Naito |
Organization
Kyoto Prefectural University of Medicine
Division name
Molecular Gastroenterology and Hepatology
Zip code
602-8566
Address
465 Kajiicho Hirokoji, Kawaramachidori, Kamigyo-ku, Kyoto, Japan
TEL
075-251-5519
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 Medicinea
Division name
Molecular Gastroenterology and Hepatology
Zip code
602-8566
Address
465 Kajiicho Hirokoji, Kawaramachidori, Kamigyo-ku, Kyoto, Japan
TEL
075-251-5519
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 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
Ethics Committee of the Kyoto Prefectural University of Medicine
Address
465 Kajiicho Hirokoji, Kawaramachidori, Kamigyo-ku, Kyoto, Japan
Tel
075-251-5337
rinri@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
| 2016 | Year | 02 | Month | 19 | Day |
Anticipated trial start date
| 2016 | Year | 02 | Month | 19 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2024 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2024 | 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
| 2022 | Year | 04 | Month | 29 | Day |
Link to view the page
Value
https://center6.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 |
