UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Microbiota analysis in chronic gastroenterological diseases.
Title of the study (Brief title)	Microbiota in chronic gastroenterological disease
Region	Japan

Condition
Condition	Chronic gastroenterological disease and hepato-biliary-pancreatic diseases
Classification by specialty	Gastroenterology Hepato-biliary-pancreatic medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To reveal the effect of microbiota changes in chronic gastroenterological and hepato-biliary pancreatic diseases. There are more than 100 species of intestinal microbiota in the gut. These microbiota resident in the intestine and affect human immune system or gastrointestinal diseases progression. Recently, a high-throughput culture-independent pyrosequencing method has enabled us to find the disease specific microbiota changes. As we are interested in the microbiota and the microbiota produced metabolites, we analyze the gut and the oral cavity mircrobiome and metabolome analysis in chronic gastroenterological diseases and hepato-biliary pancreatic diseases.
Basic objectives2	Bio-availability
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Microbiome and Metabolome analysis for disease condition: The gut and the oral cavity microbiome analysis and metabolome analysis will be performed. The correlation between disease condtion and the specific microbiota and/or metabolite will be analyzed.
Key secondary outcomes	Microbiome and Metabolome anaysis for laboratory data: Age, Liver related data;AST,ALT,gGTP,Alb,Total bilirubin Diabetes related data;FPG,IRI,HbA1c Tumor markers;CEA,CA125,CA19-9,SCC,CK19 Autoantibodies;ANA,IgG

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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
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Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Chronic gastroenterological and hepato-biliary-pancreatic disease patients who met following criteria and obtained written informed consent. 1)Chronic gastroenterological and hepato-biliary-pancreatic disease patients (Chronic inflammatory disease 110, Cancer patients110) 2) 20 years of age or more.
Key exclusion criteria	Key exclusion criteria; 1) Patients who decided not suitable by the physicians. 2) Age less than 20 and patients who can not undestand the protocol.
Target sample size	220

Research contact person
Name of lead principal investigator	Akinobu Takaki
Organization	Okayama University Graduate School of Medicine, Dentistry, and Pharamaceutical Sciences
Division name	Department of Gastroenterology and Hepatology
Address	2-5-1 Shikata Cho, Kita-Ku, Okayama City
TEL	+81-86-235-7219
Email	akitaka@md.okayama-u.ac.jp

Public contact
Name of contact person	Akinobu Takaki
Organization	Okayama University Graduate School of Medicine, Dentistry, and Pharamaceutical Sciences
Division name	Department of Gastroenterology and Hepatology
Address	2-5-1 Shikata Cho, Kita-Ku, Okayama City
TEL	+81-86-235-7219
Homepage URL
Email	akitaka@md.okayama-u.ac.jp

Sponsor
Institute	Department of Gastroenterology and Hepatology Okayama University Graduate School of Medicine, Dentistry, and Pharamaceutical Sciences
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Department of Gastroenterology and Hepatology Okayama University Graduate School of Medicine, Dentistry, and Pharamaceutical Sciences
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Japan

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

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	岡山大学病院、倉敷中央病院、岡山赤十字病院、岡山済生会総合病院、香川県立中央病院、福山医療センター

Other administrative information
Date of disclosure of the study information	2016 Year 06 Month 01 Day

Progress
Recruitment status	Recruiting
Date of protocol fixation	2015 Year 11 Month 01 Day
Anticipated trial start date	2015 Year 11 Month 11 Day
Last follow-up date	2025 Year 10 Month 31 Day
Date of closure to data entry	2025 Year 10 Month 31 Day
Date trial data considered complete	2025 Year 10 Month 31 Day
Date analysis concluded	2025 Year 12 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	We define the microbiome and metabolome analysis in the patients concerning the clinical characteristics. The 3 years clinical outcome is also included in the analysis.

Management information
Registered date	2016 Year 05 Month 05 Day
Last modified on	2016 Year 05 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025583