UMIN-CTR Clinical Trial

Basic information
Public title	Establishment of a method for evaluating the intestinal environment by integrating studies about bacterial flora in the intestine
Acronym	Development of intestinal environment evaluation system
Scientific Title	Development of intestinal environment evaluation system by integrated analysis of intestinal microbiota research database
Scientific Title:Acronym	Development of intestinal environment evaluation system by integrated analysis of intestinal microbiota research database
Region	Japan

Condition
Condition	healthy individuals without diseases, inflammatory bowel disease, diabetes, non-alcoholic fatty liver disease/non-alcoholic steatohepatitis, inflammatory bowel disease, irritable bowel syndrome, neuroimmune diseases, patients with carcinoma using immune checkpoint inhibitors for treatment, colorectal cancer, and the elderly.
Classification by specialty	Medicine in general Gastroenterology Hepato-biliary-pancreatic medicine Cardiology Pneumology Endocrinology and Metabolism Hematology and clinical oncology Nephrology Neurology Clinical immunology Infectious disease Geriatrics Adult
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	We will comprehensively analyze the primary studies (1 cohort study (precise medical care), 11 randomized controlled studies, 1 Kyotango longevity cohort study, and 1 intervention study) that we have conducted so far, and systematize the intestinal microbiota based on the background factors of diseases, disease risks, and healthy individuals.
Basic objectives2	Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Development of an automatic bacterial flora evaluation program based on the indices obtained from comprehensive integrated analysis
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	In 16 clinical studies conducted in the past (see below for details), subjects who have given permission for secondary use at the time of obtaining consent will be subjected to an integrated analysis using already analyzed and anonymized gut microbiota analysis data and subject background factors, after obtaining permission in an information disclosure document (with opt-out). Analysis will be carried out using the already analyzed and anonymized gut microbiota analysis data and subject background factors. The selection criteria will be healthy subjects or patients who are eligible for the above study.
Key exclusion criteria	If the research subject is disclosed information about this research and expresses his or her refusal to participate.
Target sample size	1700

Research contact person
Name of lead principal investigator	1st name Tomohisa Middle name Last name Takagi
Organization	Kyoto Prefectural University of Medicine
Division name	Department for Medical Innovation and Translational Medical Science
Zip code	602-8566
Address	465 Kajiicho Hirokoji Kawaramachidori Kamigyo-ku, Kyoto, Japan
TEL	075-251-5111
Email	takatomo@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	Molecular Gastroenterology and Hepatology
Zip code	602-8566
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	Department for Medical Innovation and Translational Medical Science, Kyoto Prefectural University of Medicine
Institute
Department

Funding Source
Organization	Department for Medical Innovation and Translational Medical Science, Kyoto Prefectural University of Medicine
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Ethics Committee of Kyoto Prefectural University of Medicine, Kyoto Prefectural University of Medicine
Address	465 Kajiicho Hirokoji Kawaramachidori Kamigyo-ku, Kyoto, Japan
Tel	075-251-5337
Email	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

Other administrative information
Date of disclosure of the study information	2021 Year 08 Month 22 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	2020 Year 06 Month 29 Day
Date of IRB	2020 Year 06 Month 29 Day
Anticipated trial start date	2020 Year 06 Month 29 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

This study will be conducted on subjects who have given permission for secondary use at the time of obtaining consent in the following clinical research, which has already been approved by the Medical Ethics Review Committee of Kyoto Prefectural University of Medicine, and will be analyzed in an integrated manner using data and background factors that have already been analyzed, after obtaining permission in an information disclosure document. 1. Medical Ethics Committee Approval Number: ERB-C-534-4 2. Medical Ethics Committee Approval Number: ERB-C-1480 3. Medical Ethics Committee Approval Number: ERB-C-1318 4. Medical Ethics Committee Approval Number: ERB-C-1109 5. Medical Ethics Committee Approval Number: ERB-C-1532 6. Medical Ethics Committee Approval Number: ERB-C-111 7. Medical Ethics Committee Approval Number: ERB-C-300 8. Medical Ethics Committee Approval Number: ERB-C-299 9. Medical Ethics Committee Approval Number: ERB-C-987-1 10. Medical Ethics Committee Approval Number: ERB-C-994-1 11. Medical Ethics Committee Approval Number: ERB-C-1361-1 12. Medical Ethics Committee Approval Number: ERB-C-885-1 13. Medical Ethics Committee Approval Number: ERB-C-885-1 14. Medical Ethics Committee Approval Number: ERB-C-1368-3 15. Medical Ethics Committee Approval Number: ERB-C-1379-2 16. Medical Ethics Committee Approval Number: ERB-C-1755

Management information
Registered date	2021 Year 08 Month 22 Day
Last modified on	2021 Year 08 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051653