UMIN-CTR Clinical Trial

Basic information
Public title	Association of gut microbiota with inflammation, cancer, or dysfunction in gastrointestinal diseases
Acronym	Association between gut microbiota and gastrointestinal diseases
Scientific Title	Association of gut microbiota with inflammation, cancer, or dysfunction in gastrointestinal diseases
Scientific Title:Acronym	Association between gut microbiota and gastrointestinal diseases
Region	Japan

Condition
Condition	Gastrointestinal disease associated with inflammation, cancer, or dysfunction
Classification by specialty	Gastroenterology Hepato-biliary-pancreatic medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the association of human indigenous microbiota (e.g., saliva, gastric fluid, bile, stool, urine, sweat) with the pathophysiology of gastrointestinal diseases associated with inflammation, cancer, or dysfunction.
Basic objectives2	Others
Basic objectives -Others	Clarifying pathophysiology
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Relative abundance of microbiota in 16S rRNA sequencing
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	Patients who have (or are suspected to have) a gastrointestinal disease with inflammation, cancer, or dysfunction
Key exclusion criteria	Patients whom the attending physician recognized as not suitable for this study because he / she did not have the ability to judge whether or not to participate in this study
Target sample size	1250

Research contact person
Name of lead principal investigator	1st name Hiroto Middle name Last name Furuhashi
Organization	The Jikei University School of Medicine
Division name	Department of Endoscopy
Zip code	1058471
Address	3-19-18, Nishi-Shimbashi, Minato-ku, Tokyo
TEL	03-3433-1111
Email	ms04furuhashi@jikei.ac.jp

Public contact
Name of contact person	1st name Hiroto Middle name Last name Furuhashi
Organization	The Jikei University School of Medicine
Division name	Department of Endoscopy
Zip code	1058471
Address	3-19-18, Nishi-Shimbashi, Minato-ku, Tokyo
TEL	03-3433-1111
Homepage URL
Email	ms04furuhashi@jikei.ac.jp

Sponsor
Institute	The Jikei University School of Medicine
Institute
Department

Funding Source
Organization	The Jikei University School 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	Institutional Review Board of The Jikei University School of Medicine
Address	3-19-18, Nishi-Shimbashi, Minato-ku, Tokyo
Tel	0334331111
Email	rinri@jikei.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	2020 Year 04 Month 18 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	2019 Year 09 Month 02 Day
Date of IRB	2019 Year 09 Month 02 Day
Anticipated trial start date	2019 Year 09 Month 02 Day
Last follow-up date	2024 Year 09 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Human gastrointestinal fluid spontaneously excreted or aspirated with an endoscope are analyzed using meta 16S rRNA sequencing, shotgun sequencing, metatranscriptome analysis, or metabolome analysis. Then, the relationship between sequence data and clinical severity scores is statistically analyzed.

Management information
Registered date	2020 Year 04 Month 18 Day
Last modified on	2020 Year 04 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045806